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Background Certain sociodemographic subgroups of HIV-infected patients may experience more chronic disease than others due to behavioural risk factors, advanced HIV disease or complications from extended use of combination antiretroviral therapy (cART), but recent comparative data are limited. Methods We studied HIV-infected adult patients in care during 2006–2010 who had been prescribed ≥6 months of cART. We analysed the prevalence of selected key chronic conditions and polymorbidity (having 2 or more out of 10 key conditions) by gender and race/ethnicity. Results Of the 3,166 HIV-infected patients (median age 47 years, CD4+ T-cell count 496 cells/mm3, duration of cART use 6.8 years), 21% were female, 57% were non-Hispanic White and over half were current or former tobacco smokers. The five most frequent conditions among women (median age 45 years) were dyslipidaemia (67.3%), hypertension (57.4%), obesity (31.7%), viral hepatitis B or C coinfection (29.0%) and low high-density lipoprotein cholesterol (HDLc; 27.3%). The five most frequent conditions in men (median age 47 years) were dyslipidaemia (81.2%), hypertension (54.4%), low HDLc (41.1%), elevated triglycerides (32.3%) and elevated non-HDLc (26.8%). In multivariable analyses, Hispanic patients had higher prevalence of obesity and diabetes than White patients; Black patients had higher prevalence of obesity and hypertension but lower rates of lipid abnormalities. Of all patients, 73.7% of women and 66.8% of men had polymorbidity, with no evidence of disparities by race/ethnicity. Conclusions Among contemporary cART-treated HIV-infected adults, chronic conditions and polymorbidity were common, underscoring the importance of chronic disease prevention and management among ageing HIV-infected patients.

HIV-associated neurocognitive disorders remain prevalent but challenging to diagnose particularly among non-demented individuals. To determine whether a brief computerized battery correlates with formal neurocognitive testing, we identified 46 HIV-infected persons who had undergone both formal neurocognitive testing and a brief computerized battery. Simple detection tests correlated best with formal neuropsychological testing. By multivariable regression model, 53% of the variance in the composite Global Deficit Score was accounted for by elements from the brief computerized tool (P < 0.01). These data confirm previous correlation data with the computerized battery. Using the five significant parameters from the regression model in a Receiver Operating Characteristic curve, 90% of persons were accurately classified as being cognitively impaired or not. The test battery requires additional evaluation, specifically for identifying persons with mild impairment, a state upon which interventions may be effective.

Background. Persons with human immunodeficiency virus (HIV) infection are at risk for premature cardiovascular disease (CVD). Predictors of atherosclerotic disease progression in contemporary patients have not been well described. Methods. Using data from a prospective observational cohort of adults infected with HIV (Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy), we assessed common carotid artery intima-media thickness (CIMT) at baseline and year 2 by ultrasound. We examined HIV-associated predictors of CIMT progression after adjusting for age, sex, race/ethnicity, body mass index, smoking, hypertension, diabetes, low-density lipoprotein cholesterol level, and baseline CIMT using linear regression. Results. Among 389 participants (median age at baseline, 42 years; male sex, 77%; median CD4+ cell count at baseline, 485 cells/mm3; 78% receiving antiretroviral therapy), the median 2-year CIMT change was 0.016 mm (interquartile range, −0.003 to 0.033 mm; P < .001). Lesser CIMT progression was associated with a suppressed viral load at baseline (−0.009 mm change; P = .015) and remaining virologically suppressed throughout follow-up (−0.011 mm change; P < .001). After adjusting for additional risk factors and a suppressed viral load during follow-up, nonnucleoside reverse transcriptase inhibitor versus protease inhibitor exposure was associated with lesser CIMT progression (−0.011 mm change; P = .02). Conclusions. Suppressing HIV replication below clinical thresholds was associated with less progression of atherosclerosis. The proatherogenic mechanisms of HIV replication and the net CVD benefit of different antiretroviral drugs should be a focus of future research.

Background. In the era of highly active antiretroviral therapy (HAART), human immunodeficiency virus (HIV)‐infected persons have higher cardiovascular disease risk. Little is known about asymptomatic abnormalities in cardiac structure and function in this population. Methods. The Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study) is a prospective, observational, multi-site cohort of 656 HIV-infected participants who underwent baseline echocardiography during 2004‐2006. We examined prevalence of and factors associated with left ventricular systolic dysfunction (LVSD), diastolic dysfunction (DD), pulmonary hypertension (PHTN), left ventricular hypertrophy (LVH), and left atrial enlargement (LAE). Results. Participant characteristics were as follows: median age, 41 years; 24% women; 29% non-Hispanic black; 73% receiving HAART; and median CD41 cell count, 462 cells/lL. Among evaluable participants, 18% had LVSD, 26% had DD, 57% had PHTN (right ventricular pressure .30 mm Hg), 6.5% had LVH, and 40% had LAE. In multivariate analyses, significant factors (P , .05) associated with LVSD were history of MI, elevated highly sensitive C-reactive protein (hsCRP) level, and current tobacco smoking; for DD, elevated hsCRP level and hypertension; for PHTN, current use of ritonavir; for LVH, hypertension, diabetes, non-white race, female sex with elevated body mass index, calculated as the weight in kilograms divided by the square of height in meters, of >25, elevated hsCRP level, and current use of abacavir; for LAE, hypertension and recent marijuana use. Conclusions. In this large contemporary HIV cohort, the prevalence of subclinical functional and structural cardiac abnormalities was greater than expected for age. Abnormalities were mostly associated with expected and often modifiable risks. Lifestyle modification should become a greater priority in the management of chronic HIV disease.

Treatment of human immunodeficiency virus (HIV) infection with highly active combination antiretroviral therapy has increased survival and shifted the spectrum of HIV-associated morbidity and mortality from opportunistic infections toward a variety of other medical conditions. The prospective cohort Study to Understand the Natural History of HIV and AIDS in the Era of Effective Therapy (SUN Study) monitors the clinical course of HIV-infected individuals treated with combination antiretroviral therapy in 4 US cities. Every 6 months, clinical assessments, medical record abstraction, audio computer-assisted self-interview, and neurocognitive measurements are completed and blood and urine specimens are banked centrally. At enrollment and periodically thereafter, additional techniques such as anal cytology, dual energy x-ray absorptiometry, carotid ultrasonography, echocardiography, and abdominal and cardiac computed tomography are performed. From March 2004 through June 2006, 700 participants were enrolled; median age was 41 years, 76% were men, 58% were non-Hispanic white, 62% were men who have sex with men, 78% were taking combination antiretroviral therapy (of whom 86% had an HIV viral load of

This randomised control trial, conducted in Chennai, India, compared structured interrupted therapy (SIT) and continuous therapy (CT) in relation to immunologic and virologic outcomes, adverse events (AEs) and cost of therapy. ART-naïve adult HIV1-infected participants with CD4 counts 50-350 cells/mm(3), and plasma viral load (PVL)5000 copies/mL were enrolled and placed on Indian-manufactured generic ART: zidovudine(AZT)/stavudine(d4T)+lamivudine(3TC)+efavirenz(EFV). After at least six months of continuous therapy, subjects were randomised to SIT (one-week-on/one-week-off cycles) or CT. The primary end-point was the proportion of subjects maintaining CD4200 cells/mm(3) at six and 12 months after randomisation. Secondary end-points were effective viral suppression (PVL400 copies/mL), AEs and cost. All analyses used intention-to-treat methodology. Of 40 participants (69% male; mean age 36+/-7; median baseline CD4 and PVL: 162 cell/mm(3)and 259,000 copies/mL), 17 were randomised to SIT and 18 to CT. At randomisation, median CD4s for SIT and CT were 378 cells/mm(3) and 357 cells/mm(3), respectively. All participants had PVL400 copies/mL at time of randomisation. Median CD4 six months after randomisation was 498 cells/mm(3) and 417 cells/mm(3) for SIT and CT respectively. All participants had CD4200 cells/mm(3). One participant on CT and two on SIT had sustained PVL400 copies/mL. There were no serious AEs or deaths. Structured interrupted therapy cost was half of CT. Structured interrupted therapy was effective at maintaining CD4 above 200 cells/mm(3). Adverse events were comparable in both groups, with 50% reduction in cost for SIT. Further research on such strategies may benefit resource-constrained settings.

The purpose of this study was to examine the current practices of family practice (FP) providers and their allied staff with regard to routine HIV testing in Rhode Island (RI) and Mississippi (MS). Anonymous experimenter-derived surveys were mailed to both groups of providers in 2002. The questionnaire contained five questions about their current practices and attitudes toward HIV testing as well as patient demographics. Five hundred twenty-one questionnaires were sent to American Academy of Family Practitioners (AAFP) members in RI and MS and to FPs with listings in the phone book in RI. The response rate was 52% in RI and 41% in MS. The vast majority of providers (93%) tested their high-risk patients for HIV, but less tested pregnant (57%) and other sexually active (37%) patients. The FPs in this survey wanted HIV testing to be done in the primary care setting, yet only 7% recommended HIV testing to their sexually active patients aged 18-50 in the previous year. In order not to stigmatize any specific risk group, nor to miss any patients who are unable to be identified as being "at high risk," routine testing in the primary care setting should be encouraged.

We studied HIV prevalence in couples in Chennai, India. In 56% both partners were infected. Among discordant couples, 35 men and seven women were infected. Heterosexual intercourse is the primary risk factor. Concordance was related to sex with commercial sex workers for men and to genital ulcer disease for women. Median CD4 count was 97 cells/mm3 among concordant men, 222 cells/mm3 among discordant men. Condom use increased, and frequency of sexual intercourse decreased, among all couples after HIV diagnosis.

Thomas Campbell Butler, at 63 years of age, is completing the first year of a 2-year sentence in federal prison, following an investigation and trial that was initiated after he voluntarily reported that he believed vials containing Yersinia pestis were missing from his laboratory at Texas Tech University. We take this opportunity to remind the infectious diseases community of the plight of our esteemed colleague, whose career and family have, as a result of his efforts to protect us from infection by this organism, paid a price from which they will never recover.

Approximately one-quarter of a million persons in the United States who are infected with human immunodeficiency virus (HIV) do not know it. To decrease the number of such persons, primary care providers should make HIV testing a routine component of health care. HIV testing should also be offered routinely in other settings, such as emergency departments, jails, and substance abuse treatment centers. Currently, the Centers for Disease Control and Prevention and the Infectious Diseases Society of America recommend routine HIV testing only in settings where the prevalence of HIV infection is > or =1%; in settings where the prevalence of HIV infection is

To evaluate cardiovascular risk factors in Caucasian and African American HIV+ women undergoing treatment with HAART including a protease inhibitor (PI).Anthropometric measures and fasting blood samples were obtained from 32 Caucasian and 10 African American women. Serum was analyzed for glucose, insulin, and lipid levels.The African American women were significantly older than the Caucasian women. Body mass index (BMI) was higher in the African American women, and 80% of the African American women and 47% of the Caucasian women were overweight. There were no significant differences in fasting insulin, fasting glucose, or HOMA-IR. However, African American women had significantly higher HDL levels, whereas Caucasian women had higher triglycerides and LDL. When age-matched women were compared, total as well as LDL cholesterol was significantly higher in the Caucasian women. The ratio of total cholesterol/HDL cholesterol was 3.4 +/- 1.1 in the African American women and 5.5 +/- 1.6 (p=.021) in the age-matched Caucasian women.The differences in lipid levels in HIV+ African American and Caucasian women were greater than those reported in the literature for normal women. Although the sample size is small, the data suggest that the effect of HIV infection and/or HAART on lipid levels may be different in Caucasian and African American women. Large-scale studies will be necessary to confirm these results and clarify the mechanisms involved.

Background: A major obstacle to the administration of highly active antiretroviral therapy (HAART) in resource-limited settings is the high cost of CD4 count testing. The total lymphocyte count (TLC) has been proposed as a surrogate marker to monitor immune response to therapy. Objective: To assess, in a developed country setting, the capability and clinical utility of TLC change as a surrogate marker for CD4 count change in monitoring patients on HAART. Methods: Longitudinal co-variation between changes in TLC and concomitant changes in CD4 count following the initiation of HAART was examined using a retrospective cohort study of 126 HIV-positive patients attending The Miriam Hospital, Brown University, Providence, Rl. Analyses included evaluation of the direction of TLC change as a marker for direction of CD4 change, using sensitivity and specificity; evaluation of absolute change in TLC as a marker for benchmark changes in CD4 (≥50 over 6 months, ≥100 over 12 months), using receiver-operator characteristic (ROC) curves; and a regression model of change in TLC as a function of change in CD4, to understand within-individual variation of longitudinal TLC measures. Results: In the first 24 months of HAART, the sensitivity of a TLC increase as a marker for CD4 count increase over the same time period ranged from 86-94%, and the specificity ranged from 80-85%. The median change in TLC among patients with a CD4 count rise of ≥100 cells/mm 3 at 1 year of HAART was +766 cells/mm 3 while that of patients with a CD4 count rise of

HIV/AIDS-associated and non-HIV/AIDS-associated death rates and causes of death between 1993 and 1999 were examined in 885 HIV-infected women and 425 uninfected women of the HIV Epidemiology Research Study cohort. Causes of death were determined by review of death certificates and the National Death Index. Adjusted hazard ratios were calculated for mortality risk factors. In the 885 HIV-infected women and 425 uninfected women, 234 deaths and 8 deaths, respectively, occurred by December 31, 1999. All-cause death rates in the HIV-infected women were unchanged between the pre-HAART (1993-1996) and HAART eras (1997-1999)-5.1 versus 5.4 deaths per 100 person-years (py). AIDS as a cause of death decreased from 58% of all deaths in 1996 to 19% in 1999, while HAART use increased to 42% by the end of 1999. In spite of the modest proportion ever using HAART, HIV-related mortality rates did decline, particularly in women with CD4+ cell counts less than 200/mm(3). Drug-related factors were prominent: for the 129 non-AIDS-defining deaths, hepatitis C positivity (relative hazard [RH] 2.6, P.001) and injection drug use (RH 1.7, P = 0.02) were strong predictors of mortality, but were not significant in the Cox model for 105 AIDS-defining deaths (RH 0.9, P.30 and RH 0.7, P.30, respectively. The regression analysis findings, along with the high percentage of non-AIDS deaths attributable to illicit drug use, suggest that high levels of drug use in this population offset improvements in mortality from declining numbers of deaths due to AIDS.

An association of increased weight with a slower progression of human immunodeficiency virus (HIV) disease has been reported in studies that have not included large numbers of women. We evaluated the association of HIV disease progression with body mass index (BMI) in 871 women and present cross-sectional, survival, and longitudinal analyses. A higher baseline BMI was associated with a lower rate of occurrence of the first CD4 cell count !200 cells/mm 3 . In analyses that incorporated time-varying BMI, underweight and normal women had an increased risk of clinical acquired immune deficiency syndrome, and underweight women had increased risk of HIV-related death, compared with obese women. The association between change in BMI and CD4 cell count was estimated; increases in BMI were associated with slight increases in CD4 cell counts, even after controlling for prior values of CD4 cell count, viral load, and treatment. Higher BMI and increases in BMI are associated with a decreased risk of HIV progression. The adverse effects of being overweight or obese in the general population in terms of mortality and risks of specific diseases are well known. In some situations, excess weight may be beneficial. Several published studFinancial support: National Institutes of Health (supplemental grant 2P01-DK45734-06 and grants R01-AI50505 P30-AI42853, and 1P01-DK-45734-01A2); Lifespan/Tufts/Brown Center for AIDS Research; Centers for Disease Control and Prevention (cooperative agreements U64/CCU106795, U64/CCU206798, U64/ CCU306802, and U64/CCU506831). a

Background: Data on the incidence and prognostic significance of renal dysfunction in HIV disease are limited. Objective: To determine the incidence of proteinuria and elevated serum creatinine in HIV-positive and HIV-negative women and to determine whether these abnormalities are predictors of mortality or associated with causes of death listed on the death certificate in HIV-positive women. Design: The incidence of proteinuria or elevated serum creatinine and mortality was assessed in a cohort of 885 HIV-positive women and 425 at-risk HIV-negative women. Setting: Women from the general community or HIV care clinics in four urban locations in the United States. Outcome Measures: Creatinine of ≥1.4 mg/dL, proteinuria 2 + or more, or both. Deaths confirmed by a death certificate (92%) or medical record/community report (8%). Results: At baseline, 64 (7.2%) HIV-positive women and 10 (2.4%) HIV-negative women had proteinuria or elevated creatinine. An additional 128 (14%) HIV-positive women and 18 (4%) HIV-negative women developed these abnormalities over the next (mean) 21 months. Relative hazards of mortality were significantly increased (adjusted relative hazard = 2.5; 95% confidence interval: 1.9-3.3), and there were more renal causes recorded on death certificates (24/92 (26%) vs. 3/127 (2,7%), p

Background: In a previously reported study, 21 women (propositi) who reported changes in body habitus during highly active antiretroviral therapy (HAART) were evaluated and compared with 21 women (comparison group) on HAART who did not report body habitus changes. Mean durations of HAART at baseline evaluation were 12.5 and 15.2 months for the propositi and comparison group, respectively. Objective: Follow-up of the propositi and comparison group was conducted to determine whether body habitus changes and lipid abnormalities are progressive. stable, or improved with time and alteration of the HAART regimen. Methods: Patients were evaluated by standardized interview, physical examination, body weight, body mass index, CD4 cell count, plasma HIV RNA levels, and lipid profiles. Results: Fourteen of 21 propositi were available for follow-up. The mean duration of HAART was 42.7 months; body habitus changes were stable in 10 of the 14 women. Thirteen of 21 women in the comparison group were available for follow-up after a mean duration of HAART of 38.5 months; 2 of the 13 women had developed body habitus changes at follow-up. In both groups, mean serum lipid values at follow-up remained elevated to levels associated with increased cardiovascular risk. Conclusions: Body habitus changes in women most often developed within I year of initiation of HAART. Changes were largely stable after 2.5 additional years of HAART. Only modest and inconsistent improvement was achieved with alteration in the HAART regimen. Serum lipid abnormalities evident within the first year of HAART were also stable with 2.5 additional years of therapy.

Objective: To determine whether highly active retroviral therapy (HAART) is associated with better neurocognitive outcome over time among HIV-infected women with severely impaired immune function. Methods: A semiannual neurocognitive examination on four tasks was administered: Color Trail Making, Controlled Oral Word Association, Grooved Pegboard and FourWord Learning. This protocol was initiated in the HIV Epidemiological Research study (HERS) study when a woman's CD4 cell count fell to < 100 × 10 6 cells/l. Immune function (CD4), viral load status and depression severity (CESD) were also assessed semi-annually, along with an interview to determine medication intake and illicit drug use. Results: HAART was not available to any participant at the time of enrollment (baseline), while 44% reported taking HAART at their most recent visit (mean duration of HAART 36.3 ± 12.6 months). HAART-treated women had improved neurocognitive performance compared with those not treated with HAART. Women taking HAART for 18 months or more showed the strongest neurocognitive performance with improved verbal fluency, psychomotor and executive functions. These functions worsened among women not taking HAART. Substance abuse status, severity of depressive symptoms, age and educational level did not influence the HAART treatment effects on neurocognitive performance. Neurocognitive improvements were strongly associated with the magnitude of CD4 cell count increases. Conclusions: HAART appeared to produce beneficial effect on neurocognitive functioning in HIV-infected women with severely impaired immune systems. Benefits were greatest for women who reported receiving HAART for more than 18 months.

In the past 5 years, options for antiretroviral therapy have rapidly increased. Between 1987 and 1991, zidovudine was the only available agent for the treatment of HIV disease. In 1988, the FDA implemented new regulations allowing for accelerated approval of drugs used in the treatment of HIV/AIDS. Didanosine, zalcitabine, and lamivudine were approved in 1991, 1992, and 1995, respectively. Since 1995, at least 10 new agents have been approved, including two novel classes of antiretrovirals: protease inhibitors (PI) and nonnucleoside reverse transcriptase inhibitors (NNRTI). Current guidelines recommend the use of multiple concurrent antiretroviral medications, combining agents from different classes to form highly active antiretroviral therapy (HAART).32 Patients are surviving much longer, with increased exposure to medications, to chronic infection, and to the effects of aging. As a consequence, the problem of managing unanticipated, often overlapping and sometimes chronic toxicities has arisen. This article provides an overview of the complications of antiretroviral therapy and suggests guidelines for their management. The more serious or long-term toxicities of each class of antiretrovirals are discussed in detail. For other common adverse effects, the associated agents, incidence, and management are summarized in Table 1.

Objectives The purpose of this study was to examine the impact of neurocognitive and emotional distress and immune system dysfunction on quality of life in women with HIV. Methods Thirty-six HIV-seropositive women were administered measures of mood status (Profile of Mood States), quality of life (Multidimensional Quality of Life Questionnaire for Persons with HIV) and cognitive function. CD4 cell counts were obtained as an indicator of immune system status. Results Regression analyses revealed that independent of severity of emotional distress, neurocognitive deficits on measures of executive control and speed of information processing were associated with reduced quality of life. Emotional status also was associated with quality of life and together with neurocognitive performance accounted for most of the variance associated with quality of life. Reduced CD4 cell count was significantly associated with neurocognitive deficits, but not severity of emotional distress or quality of life. Conclusions Quality of life among women who are infected with HIV is strongly influenced by both neurocognitive and emotional status, as women with the greatest neurocognitive impairment and emotional distress report the poorest quality of life.

OBJECTIVES: To compare the prevalence of HIV-related symptoms, physical examination findings, and hematologic variables among women whose risk for HIV is injection drug use since 1985 as opposed to sexual contact and to evaluate the influence of HIV plasma viral load and CD4+ cell count on clinical manifestations according to risk. METHODS: Participants of the HIV Epidemiology Research Study (HERS; a multicenter, prospective, controlled study of HIV infection in women) were administered a risk behavior and symptom interview, underwent a physical examination, and received hematologic testing, including CD4+ cell counts done on study entry. Plasma HIV-1 viral loads were performed on stored frozen plasma using an ultrasensitive branched-DNA (b-DNA) signal amplification assay. CD4+ counts were categorized as or =500 cells/microl, and HIV viral loads were characterized in tertiles. RESULTS: Cross-sectional analysis was conducted on data available for 724 HIV-infected women: 387 had a history of intravenous drug use and 337 were infected through heterosexual contact. The median CD4+ count was 376 cells/microl; the median HIV-1 viral load was 1135 copies/ml; and 281 of 724 HIV-infected women (38.8%) had an undetectable HIV-1 viral load. In analyses adjusting for CD4+ cell level alone and for plasma viral load combined with CD4+ cell level, injection drug users (IDUs) were more likely than those infected through heterosexual contact to report a recent episode of memory loss and weight loss, but less likely to have recent episodes of genital herpes; to have enlarged livers and a body mass index (BMI)

The epidemiology of mucosal candidal colonization and candidiasis was studied in a multicenter cohort of 871 human immunodeficiency virus (HIV)-seropositive and 439 demographically and behaviorally similar HIV-seronegative women. Cross-sectional analyses at baseline revealed that oropharyngeal colonization with Candida species was more prevalent among seropositive women and among women reporting recent cigarette smoking and injection drug use. Oropharyngeal candidiasis was also more prevalent among seropositive women. Both oropharyngeal colonization and candidiasis were significantly associated with a lower median CD4 lymphocyte count among seropositive women. Vaginal candidal colonization was more prevalent among seropositive women and among those reporting recent injection drug use and current insulin or oral antihyperglycemic therapy. Vaginal candidiasis was equally likely to be diagnosed in seropositive and seronegative women and was not significantly related to recent sexual contact. Neither vaginal colonization nor candidiasis was significantly related to a lower median CD4 lymphocyte count among seropositive women. Baseline evaluation indicated differences in the epidemiology of oropharyngeal and vaginal candidal colonization and candidiasis in HIV-seropositive women and suggested possible variation in pathogenesis of candidal infection at these two mucosal sites.

To estimate the prevalence and to identify correlates of physical and sexual assaults or abuse among women with or at risk for HIV infection, a cross-sectional survey was conducted within a longitudinal cohort study. A total of 765 HIV-seropositive and 367 HIV-seronegative women with a history of injection drug use (51%) or high-risk sex (49%) completed the interview. Both physical abuse and sexual abuse as a child were common for both HIV-seropositive (41.3%, 41.0%) and uninfected women (43.3%, 45.8%), respectively. Both physical abuse and sexual abuse as adults were even more common in both HIV-seropositive (66.4%, 45.7%) and HIV-seronegative women (69.2%, 48.8%), respectively. In the 6 months prior to interview, the most important predictors for being the victim of violence was age

Interest in global health (GH) among medical students worldwide is measurably increasing. There is a concomitant emphasis on emphasizing globally-relevant health professions education. Through a structured literature review, expert consensus recommendations, and contact with relevant professional organizations, we review the existing state of GH education in US medical schools for which data were available. Several recommendations from professional societies have been developed, along with a renewed emphasis on competencies in global health. The implementation of these recommendations was not observed as being uniform across medical schools, with variation noted in the presence of global health curricula. Recommendations for including GH in medical education are suggested, as well as ways to formalize GH curricula, while providing flexibility for innovation and adaptation.

Women constitute the fastest growing segment of adults with acquired immunodeficiency syndrome (AIDS), representing 18% of all cases in the United States in 1994. Heterosexual transmission is now the dominant route by which women are infected. Recent reports indicate that although certain manifestations may be different in women than in men, the rate of clinical progression is similar when they receive comparable medical treatment. Antiretroviral therapy is equally as effective in women as in men. As in men, Pneumocystis carinii pneumonia is the most frequent AIDS-defining diagnosis in women. Candida esophagitis and ulcers secondary to herpes simplex virus are more common in women. Kaposi's sarcoma is rare. The prevalence of humanpapilloma virus infection and cervical neoplasia is increased in HIV-seropositive women. Vaginitis due to candida, trichomonas, and bacterial vaginosis are common findings among human immunodeficiency virus seropositive women. The clinical course and response to therapy in certain sexually transmitted diseases (syphilis and herpes) may be altered. The use of zidovudine during pregnancy and delivery has been associated with a 67.5% reduction in vertical transmission.

The President's Emergency Plan for AIDS Relief (PEPFAR) was originally authorized in 2003 with the goal of supporting HIV prevention, treatment, and care within fifteen focus countries in the developing world. By September 2011 nearly 13 million people around the world were receiving HIV/AIDS-related care through PEPFAR, and 3.9 million were receiving antiretroviral treatment. However, in the early years of the program, access to antiretroviral drugs was hampered by the lack of a licensing process that the US government recognized for generic versions of these medications. Ultimately, the obstacle to approval of generic antiretroviral drugs was removed, which led to PEPFAR's considerable success at making these treatments widely available. This article outlines PEPFAR's evolving use of generic antiretroviral drugs to treat HIV in the developing world, highlights ongoing initiatives to increase access to generic antiretrovirals, and points to the need for mechanisms that will speed up the approval of new generic drugs. The striking decline in antiretroviral treatment costs, from $1,100 per person annually in 2004 to $335 per person annually in 2012, is due to the availability of effective generic antiretrovirals. Given growing resistance to existing drugs and the planned expansion of treatment to millions more people, access to newer generations of generic antiretrovirals will have to be expedited.

The magnitude and the scope of health care problems posed by human prison inmates seropositive for the human immunodeficiency virus (HIV) are enormous. Prisoners represent a substantial proportion of HIV-infected individuals in North America. A high proportion of prisoners are intravenous drug users who often have not received appropriate health care or HIV-directed services prior to incarceration. Health care of HIV-seropositive prisoners and follow-up medical care after prison release has often been less than optimal. Among inmates at the prison facility in Rhode Island, 4 % of the men and 12% of the women are HIV seropositive. The Brown University medical community, in conjunction with the Rhode Island Department of Health and Corrections, has developed an effective program for the health care of such prisoners, both during incarceration and after release from prison. Academic medical centers are uniquely poised to assume the leading role in meeting this obligation. We believe that this general approach, with region-specific modifications, may be effectively applied in many correctional institutions in North America.

We assessed the effect of lower genital tract infections on human immunodeficiency virus type 1 (HIV-1) RNA shedding in the female genital tract. Bacterial vaginosis was significantly associated with HIV-1 RNA expression in the female genital tract of HIV-infected women.

Human immunodeficiency virus (HIV) infection in women is increasing rapidly in North America and worldwide. The decline of CD4 lymphocyte counts from the time of seroconversion has been ex...

As reviewed in previous chapters of this work, the earliest vaccines were of the live variety, either based on a naturally occurring weaker version of pathogen, as with Jenner’s use of cowpox, or the laboratory-manipulated, attenuated forms of anthrax and rabies employed by his vaccine heir, Pasteur. The next important concept in vaccine science, killed vaccines, was introduced in animals almost concurrently with Pasteur’s live vaccines, but it took another decade for the realization of its clinical application. In 1886, Theobald Smith and his laboratory chief, Daniel Salmon, developed arguably the first successful, heat killed vaccine against the agent of hog cholera while working at the U.S. Department of Agriculture (Zinsser 1987). In the waning years of the nineteenth century, following closely on the heels of a half-century of stunning advances in microbiology and its sister science, immunology, killed vaccines were developed against three major bacterial causes of human morbidity and mortality of the time that flourished amidst the nineteenth century’s primitive sanitation and underdeveloped public health practices: cholera, typhoid, and plague.

Over the next 12 months, many additional cases of PCP pneumonia, Kaposi’s sarcoma, and cryptococcal meningitis were identified in young MSMs, especially in major US cities on the East and West coasts. In most cases, the individuals had no prior indication of immunodeficiency, which provided the basis for nomenclature of AIDS that was applied to this syndrome by the CDC in 1982.

This study was designed to define the epidemiology and natural history of human immunodeficiency virus (HIV) infection in women in Rhode Island. Two hundred women referred to Brown University physicians from 1986 through 1990 were evaluated at 3-to-6-month intervals for 12 to 60 months. All received antiretroviral therapy and prophylaxis against opportunistic infections when indicated on the basis of CD4 lymphocyte counts. Major findings included: 1) rapid shift of dominant mode of transmission from intravenous drug sharing to heterosexual route; 2) significant gender-specific differences in clinical presentation; 3) increased frequency of cervical dysplasia in women infected via intravenous needle sharing; 4) no definite gender-specific differences in progression of HIV infection; 5) enormous societal impact of HIV infection in women. Principal conclusions are: 1) rapid change to predominantly heterosexual HIV transmission can occur in North America, with serious societal impact; 2) gender-specific clinical features can lead to earlier diagnosis of HIV infection in women; 3) HIV infection in women does not pursue an inherently more rapid course than that observed in men.

Study objective:To describe the reasons for the HIV testing of HIV-positive women and their clinical presentation and to make specific laboratory comparisons between women intravenous drug users (IVDUs) and non-IVDUs who were heterosexually infected (HTs). Design:Consecutive case series. Setting:Four primary care sites associated with the Brown University AIDS Program. Participants:140 consecutive HIV-seropositive women. Results:The most common reason for HIV testing in both groups was self-perception of risk. Presenting T-helper lymphocyte counts, leukocyte counts, and hematocrits did not differ significantly between the groups. Intravenous drug users were significantly more likely than HTs to have evidence of hepatitis B virus exposure (p

Vertical transmission of human immunodeficiency virus (HIV) accounts for most new pediatric cases in the United States. With the routine use of zidovudine in the antepartum, intrapartum, and postnatal periods, transmission of HIV from mother to infant has decreased significantly during the past 5 years. Most transmission occurs during labor and delivery, so the effect of mode of delivery recently has been investigated. Several studies support cesarean to further reduce infection in newborns. However, those studies are limited by lack of data on concomitant effects of viral load and effects of combined antiretroviral therapy. There also might be increased operative morbidity in this population. Therefore, we suggest caution in establishing cesarean as a standard for delivery of HIV-infected women.

purpose: Candida is the most common cause of opportunistic mucosal infections in human immunodeficiency virus (HIV)-positive women. We had observed an apparent correlation between the severity of immunodeficiency and the site of mucosal candida infection. The current study was designed to determine whether significant correlations existed between the sites of mucosal candida infection and the degree of immunodeficiency, as determined by subsets of lymphocyte populations. patients and methods: The subjects in this study are 66 HIV-seropositive women evaluated by members of the Brown University Acquired Immunodeficiency Syndrome (AIDS) Program during the 3-year period, September 1, 1986, through August 30, 1989. All patients had thorough clinical evaluations and relevant laboratory studies at defined intervals. All patients with CD4 lymphocyte counts below 0.2 × 10 9 /L received zidovudine therapy as soon as it became available. After July 1988, all patients with CD4 counts below 0.2 × 10 9 /L received prophylaxis against Pneumocystis carinii pneumonia. All patients were counseled about HIV infection, its modes of transmission, and the early symptoms of opportunistic infections. results: The longitudinal data demonstrated that candida often infected vaginal mucosa when there was no significant reduction in CD4 lymphocyte counts. Candida infection of the oropharyngeal mucosa was associated with highly significant reductions in CD4 lymphocyte counts. Esophageal candidiasis occurred only with advanced immunodeficiency associated with CD4 counts below 0.1 × 10 9 /L. conclusions: Candida mucosal infections occur in a hierarchical pattern in women with HIV infection. Determination of the basis for the differences in susceptibility to candida of the vaginal, oropharyngeal, and esophageal mucosal surfaces will require further studies.

Context Guidelines for antiretroviral therapy are important for clinicians worldwide given the complexity of the field and the varied clinical situations in which these agents are used. The International AIDS Society–USA panel has updated its recommendations as warranted by new developments in the field. Objective To provide physicians and other human immunodeficiency virus (HIV) clinicians with current recommendations for the use of antiretroviral therapy in HIVinfected adults in circumstances for which there is relatively unrestricted access to drugs and monitoring tools. The recommendations are centered on 4 key issues: when to start antiretroviral therapy; what to start; when to change; and what to change. Antiretroviral therapy in special circumstances is also described. Data Sources and Study Selection A 16-member noncompensated panel was appointed, based on expertise in HIV research and patient care internationally. Data published or presented at selected scientific conferences from mid 2004 through May 2006 were identified and reviewed by all members of the panel. Data Extraction and Synthesis Data that might change previous guidelines were identified and reviewed. New guidelines were drafted by a writing committee and reviewed by the entire panel. Conclusions Antiretroviral therapy in adults continues to evolve rapidly, making delivery of state-of-the-art care challenging. Initiation of therapy continues to be recommended in all symptomatic persons and in asymptomatic persons after the CD4 cell count falls below 350/µL and before it declines to 200/µL. A nonnucleoside reverse transcriptase inhibitor or a protease inhibitor boosted with low-dose ritonavir each combined with 2 nucleoside (or nucleotide) reverse transcriptase inhibitors is recommended with choice being based on the individual patient profile. Therapy should be changed when toxicity or intolerance mandate it or when treatment failure is documented. The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL. Adherence to antiretroviral therapy in the short-term and the long-term is crucial for treatment success and must be continually reinforced.

The objective was to describe reasons for modification and discontinuation of antiretroviral regimens in association with adverse events (AEs) treatment failure and cost among patients in southern India. Secular trends of patients initiating highly active antiretroviral therapy (HAART) between January 1996 and October 2004 at a tertiary HIV referral center in India were analyzed using a previously validated natural history database. All previously antiretroviral therapy-naive patients who initiated HAART (N = 1443) and had at least 1 follow-up visit were evaluated. The median CD4 count at the time of initiating HAART was 108 cells/mL The most common first-line regimens were stavudine (d4T) plus lamivudine (3TC) plus nevirapine (NVP) (63%) zidovudine (AZT) plus 3TC plus NVP (19%) d4T plus 3TC plus efavirenz (EFV) (9%) and AZT plus 3TC plus EFV (4%). Twenty percent of patients modified their first-line regimen. The most common reason for modifying therapy was the development of an AE (64%) followed by cost (19%) and treatment failure (14%) with median times to modify therapy being 40 151 and 406 days respectively. Common AEs were itching and/or skin rash (66%) hepatotoxicity (27%) and anemia (23%). Nine percent of patients discontinued therapy entirely after a median duration of 124 days primarily because of cost (64%). The most common reason for modifying therapy was the occurrence of AEs whereas cost was the most common reason for discontinuing therapy. Despite increasing access to lower cost generic HAART in India even less expensive and more tolerable first-line regimens and cost-effective treatment monitoring tools need to be introduced to achieve better treatment outcomes and access in resource-constrained settings. (authors)

We prospectively studied the initial results of 6 months of generic efavirenz-based therapy on the plasma viral load in 40 patients at YRG Centre for AIDS Research and Education, a tertiary HIV referral centre in southern India. The median baseline plasma viral load was 259 000 copies/ml and at 6 months 95% of patients had plasma viral loads less than 400 copies/ml. The data support the use of generic non-nucleoside reverse transcriptase inhibitor-based regimens in resource-limited settings.

Developing a vaccine that will stimulate broad HIV-specific T cell responses is difficult because of the variability in HIV T cell epitope sequences, which is in turn due to the high mutation rate and consequent strain diversity of HIV-1. We used a new Class II version of the EpiMatrix T cell epitope-mapping tool and Conservatrix to select highly conserved and promiscuous Class II HLA-restricted T cell epitopes from a database of 18,313 HIV-1 env sequences. Criteria for selection were: (1) number of HIV-1 strains represented as measured by Conservatrix; (2) EpiMatrix score; and (3) promiscuity (number of unique MHC motifs contained in the peptide). Using another vaccine design tool called the EpiAssembler, a new set of overlapping, conserved and immunogenic HIV-1 peptides were engineered creating extended "immunogenic consensus" sequences. Each overlapping 9-mer of the 20-23 amino acid long immunogenic consensus peptides was conserved in a large number (range 893-2254) of individual HIV-1 strains, although the novel peptides were not representative of any single strain of HIV. We synthesized nine representative peptides. T helper cell responses to the peptides were evaluated by ELISpot (gamma-interferon) assay, using peripheral blood monocytes (PBMC) obtained from 34 healthy long term non-progressor (LT) or moderate-progressor (MP) donors (median years infected = 8.88, median CD4 T cells = 595, median VL = 1044). Nine peptides were tested, of which eight were confirmed in ELISpot assays using PBMC from the LT/MP subjects. These epitopes were ranked by Conservation and EpiMatrix score 1, 2, 3, 5, 7, 11, and 14 out of the set of 9 original peptides. Five of these peptides were selected for inclusion in an epitope-driven cross-clade HIV-1 vaccine (the GAIA vaccine). These data confirm the utility of bioinformatics tools to select and construct novel "immunogenic consensus sequence" T cell epitopes for a globally relevant vaccine against HIV.

Six women with substance abuse and poor adherence histories received daily antiretroviral directly observed therapy (DOT). Cervicovaginal lavage (CVL) and plasma HIV-1-RNA levels were measured at baseline, 1 month, 3 months, and 6 months. All subjects had undetectable (below 2.6 log10 copies/ml) CVL HIV-1-RNA levels by 3 months and undetectable plasma HIV-1-RNA levels by 6 months. The mean CD4 cell increase was 76 cells/mm3. DOT appears effective and may reduce infectiousness in this high-risk population.

To examine factors associated with clinical and immunologic HIV disease progression in a cohort of US women.Analysis of data from a prospective, longitudinal, case-control study of HIV-infected women followed every 6 months for 7 years.Four urban clinical centers in the United States.648 HIV-infected women who did not have AIDS at time of entry into the study.Structured clinical and behavioral interviews; protocol-directed physical examinations; CD4 lymphocyte counts; plasma HIV RNA; infectious pathogen serologies. RESULTS With 2304 women-years of follow-up, 46.1% of the women developed AIDS; however, 93.3% of the diagnoses were based on CD4 counts dropping to200 cells/mm(3). Only 10.6% of the women with CD4 counts200 cells/mm(3) developed an opportunistic infection. Baseline CD4 count was the strongest predictor of subsequent clinical progression. Illicit substance use, multiple pregnancies, demographic variables, and other infections were not associated with progression. Among women with CD4 counts500 cells/mm(3) at baseline, those who were anemic or had hepatitis C were more likely to progress to AIDS. By the end of the study, only 52% of the participants were on highly active antiretroviral therapy (HAART).Despite underutilization of HAART in this multicenter cohort of urban women, opportunistic infections were uncommon, despite CD4 declines.

Two studies reported in this issue of the Journal 1,2 provide heartening news of the success of a new antiretroviral drug in decreasing plasma human immunodeficiency virus (HIV) RNA levels in patients for whom the available combination antiretroviral regimens are no longer effective. These reports are especially noteworthy in that they describe the first controlled trials of the fusion inhibitor enfuvirtide, a representative of a new class of drugs that prevent the entry of HIV type 1 (HIV-1) into the target cells of the host.3 Enfuvirtide specifically prevents the fusion of the HIV-1 transmembrane (gp41) glycoprotein with the CD4 receptor . . .

Background: In most resource-constrained countries, CD4 cell count testing is prohibitively expensive for routine clinical use and is not widely available. As a result. physicians are often required to make decisions about opportunistic infection (OI) chemoprophylaxis without a laboratory evaluation of HIV stage and level of immunosuppression. Objectives: To evaluate the correlation of total lymphocyte count (TLC), an inexpensive and widely available parameter, to CD4 count. To determine a range of TLC cutoffs for the initiation of OI prophylaxis that is appropriate for resource-constrained settings. Methods: Spearman correlation between CD4 count and TLC was assessed in patients attending an HIV/AIDS clinic in South India. Positive predictive value (PPV), negative predictive value (NPV), and sensitivity and specificity of various TLC cutoffs were computed for CD4 count

ObjectiveNew information warrants updated recommendations for the 4 central issues in antiretroviral therapy: when to start, what drugs to start with, when to change, and what to change to. These updated recommendations are intended to guide practicing physicians actively involved in human immunodeficiency virus (HIV)– and acquired immunodeficiency syndrome (AIDS)–related care.ParticipantsIn 1995, physicians with specific expertise in HIV-related basic science and clinical research, antiretroviral therapy, and HIV patient care were invited by the International AIDS Society-USA to serve on a volunteer panel. In 1999, others were invited to broaden international representation. The 17-member panel met regularly in closed meetings between its last report in 2000 and April 2002 to review current data. The effort was sponsored and funded by the International AIDS Society-USA, a not-for-profit physician education organization.Evidence and Consensus ProcessThe full panel was convened in late 2000 and assigned 7 section committees. A section writer and 3 to 5 section committee members (each panel member served on numerous sections) identified relevant evidence and prepared draft recommendations. Basic science, clinical research, and epidemiologic data from the published literature and abstracts from recent (within 2 years) scientific conferences were considered by strength of evidence. Extrapolations from basic science data and expert opinion of the panel members were included as evidence. Draft sections were combined and circulated to the entire panel and discussed in a series of full-panel conference calls until consensus was reached. Final recommendations represent full consensus agreement of the panel.ConclusionsBecause of increased awareness of the activity and toxicity of current drugs, the threshold for initiation of therapy has shifted to a later time in the course of HIV disease. However, the optimal time to initiate therapy remains imprecisely defined. Availability of new drugs has broadened options for therapy initiation and management of treatment failure, which remains a difficult challenge.

The purpose of our study was to identify the types and rates of cancers seen in high-risk human immunodeficiency virus (HIV)-infected and HIV-uninfected women. From 1993 to 1995, 1,310 women enrolled at four urban U.S. research sites in the HIV Epidemiology Research Study and were interviewed biannually to identify interval diagnoses and hospitalizations until study closure in March 2000. Cancer incidence data were collected through abstraction of medical records and death certificates. Of 871 HIV-infected and 439 HIV-uninfected women, 85% had a history of smoking and 50% a history of injection drug use. For our analysis, 4,180 person-years were contributed by HIV-infected women, and 2,308 person-years by HIV-uninfected women. HIV-infected women had 8 non-Hodgkin's lymphomas, 5 invasive cervical cancers (ICC), 1 Kaposi's sarcoma and 12 non-AIDS defining cancers, including 4 lung cancers, compared with 4 cancers in HIV-uninfected women including 1 lung cancer (all cancers, 6.22/1000 person-years vs. 1.73/1000 person-years, p = 0.01). CD4+ cell counts were above 200/mm3 in all women with ICC. HIV-infected women with lung cancer were young smokers (mean age, 40 years), and all died within 6 months of diagnosis. Lung cancer occurred at twice the rate in HIV-infected vs. uninfected women in the cohort and severalfold above expected in age- and race-matched women in U.S. national data (incidence relative risk 6.39; 95% confidence interval 3.71, 11.02; p < 10(-7)). The frequent occurrence of cervical and lung cancers have important implications for the counseling (cigarette cessation), screening (PAP smears) and care of women with HIV infection, as they live longer because of current antiretroviral therapies.

The impact of protease inhibitors (PIs) on emergency department (i.e., emergency room [ER]) visits and hospitalizations was examined among a cohort of human immunodeficiency virus (HIV)-infected and high-risk women followed-up in the HIV Epidemiology Research Study (HERS) from 1993 through 1999. The rates of hospitalization and ER visits were measured as a function of recent or current PI use, age, race, transmission risk category, HERS site, baseline CD4 cell count, and baseline virus load; the PI effect was estimated separately by baseline CD4 cell count. In the HERS, PI use was strongly associated with lower rates of ER visits and hospitalizations for patients with baseline CD4 cell counts of

OBJECTIVE To characterize HIV-1 specific cellular immune responses at mucosal surfaces using a rapid, sensitive enzyme-linked immuno-spot (ELISPOT) technique. DESIGN Cervicovaginal mononuclear cells obtained from cytobrush and cervicovaginal lavage were assessed for production of interferon-gamma (IFN-gamma) in response to stimulation by HIV-1 antigens. HIV-1 specific responses were compared in a cross-sectional study of two HIV-1-positive patient groups: women not currently on antiretroviral therapy with peripheral CD4 cell counts > 250 x 10(6)/l (n = 12); and women on highly active antiretroviral therapy (HAART) (n = 9). METHODS Mononuclear cells from peripheral blood or cervicovaginal specimens were assessed in an ELISPOT assay for responses to HIV-1 antigens expressed by recombinant vaccinia viruses. This assay detects primarily CD8 T cells and shows good correlation with MHC class I tetramer staining of cytotoxic T lymphocytes. RESULTS HIV-1 specific IFN-gamma spot-forming cells were detected in cervicovaginal samples of one out of nine women (11%) on HAART and five out of 12 women (42%) not currently on HAART. In peripheral blood mononuclear cells, HIV-1 specific IFN-gamma spot-forming cells were significantly more numerous in women not currently on HAART than in women on HAART (P = 0.009). In most cases, antigens recognized by mucosal T cells were also recognized by PBMC; however, there were exceptions. CONCLUSIONS HIV-1-specific antigen-reactive T cells may be detected in routine, noninvasive gynecological specimens. The results suggest that cervicovaginal HIV-1-specific T cells may be less numerous in individuals on HAART than in those not on HAART, as shown previously for HIV-1-specific cytotoxic T lymphocytes in the peripheral blood.

Randomised, controlled trial data show that combination antiretroviral therapy for HIV-1 infection benefits people with CD4-cell counts less than 350 cells/microL. Based on currently known risks and benefits, we believe that if CD4-cell counts and viral load are monitored carefully, and highly active antiretroviral therapy (HAART) is started commonly when the CD4-cell count drops below 350 cells/microL, then clinically relevant immune-system damage and progression to AIDS and death can be greatly delayed or prevented. This approach is dictated by three features of HIV-1 infection that are not typical of infectious diseases: no available regimen can eradicate HIV-1; all currently effective regimens may cause undesirable, sometimes life-threatening, toxic effects; and, unless regimens are strictly adhered to, multidrug resistance can develop, limiting future treatment options. If therapy is started too early, cumulative side-effects of the drugs used and the development of multidrug resistance may outweigh the net benefits of the lengthening of life. If therapy is started too late, increases in disease progression and mortality outweigh the risk of adverse events. A patients' activist (MH) and a clinician (CCJC) discuss data that justify this balanced approach and the feasibility of randomised controlled trials to provide clearer answers about when to start treatment.

Objectives: To determine the frequency of cervicovaginal lavage and plasma HIV-1 RNA levels that are below detectable levels (< 400 copies/ml) among women on highly active antiretroviral therapy (HAART), non-HAART and on no therapy. To compare the effect of initiating HAART on the timing of HIV-1 RNA suppression in the blood plasma and genital tract among antiretroviral-naive women. Methods: Data were obtained from 205 HIV-infected women with paired plasma and cervicovaginal lavage viral load measurements. Seven antiretroviral-naive women starting HAART had viral load measurements performed daily for one week, at 2 weeks and at 1 month after initiating therapy. Viral load quantification was carried out by nucleic acid sequence-based amplification assay. The lower limit of detection was 400 copies/ml. Results: Plasma and cervicovaginal HIV-1 RNA was detectable in 71 and 26% of the women, respectively. Among women with plasma viral loads less than 400, 400-9999, and 10 000 copies/ml or over, genital tract HIV-1 RNA was detected in 3, 17 and 48%, respectively (P< 0.001). Fifty-one per cent of the women with CD4 cell counts of less than 200/mm 3 had detectable cervicovaginal viral loads compared with 18% among women with CD4 cell counts of 200/mm 3 or over (P< 0.001). Cervicovaginal HIV-1 RNA was less than 400 copies/ml in 85% of those on HAART, 69% of those on non-HAART and 69% of those on no therapy (P< 0.045). In seven antiretroviral-naive women initiating HAART, cervicovaginal HIV-1 RNA decreased by 0.7-2.1 log 10 within 1-14 days of starting therapy. Conclusion: The cervicovaginal HIV-1 RNA level was positively correlated with plasma HIV-1 RNA and negatively with the CD4 cell count. The use of HAART was significantly associated with below-detectable levels of HIV-1 RNA in both plasma and the genital tract. HIV-1 RNA suppression in the genital tract may occur rapidly after initiating therapy.