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We report a prospective study of mouse brain derived inactivated Japanese encephalitis (JE) vaccine, given in 3-dose EPI program to human immune deficiency virus (HIV)-exposed Thai infants. 18 HIV-infected receiving antiretroviral therapy with median baseline CD4 of 33.1%, and 92 HIV-uninfected children were studied. All but one HIV-infected child seroconverted after the second dose. The geometric mean titers (GMTs) 3 months after the second and third doses in HIV-infected vs HIV-uninfected children were 247 vs 938 (p = 0.022), and 2273 vs 24069 (p = 0.009), respectively. Urticaria or angioedema found in 4% and 6% in HIV-infected and -uninfected children, respectively (p = 1.0). The vaccine was safe and immunogenic but antibody response in HIV-infected children was not as high as in uninfected children.

Summary Background Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART) has been the most affordable regimen for the HIV-infected in developing countries. There are limited data comparing nevirapine (NVP) to efavirenz (EFV) in HIV-infected children. This study aimed to assess the efficacy and tolerability of NVP-based regimens compared to EFV-based regimens in HIV-infected children in Thailand. Methods The medical records of HIV-infected children who had received NNRTI-based regimens for more than 6 months at the Department of Pediatrics, Siriraj Hospital, Mahidol University, Thailand, were reviewed. Results Of the 139 HIV-infected children studied, 70 were male, and the median age at treatment initiation was 6.08 years (range 0.32–14.56 years); the median duration of follow-up was 36 months (range 6–66 months). The median baseline CD4 cell count was 185cells/mm 3 (range 2–3482cells/mm 3 ) and the median baseline CD4 percentage was 7.20% (range 0.11–36.57%). An NVP-based regimen was initiated in 61 (44%): 38 antiretroviral (ARV)-naive and 23 ARV-experienced. An EFV-based regimen was initiated in 78 (56%): 34 ARV-naive and 44 ARV-experienced. The CD4 cell count and percentage gains were not different between the NVP and EFV groups in both the ARV-naive and the ARV-experienced. However, ARV-naive children who received an EFV regimen had significantly lower baseline CD4 levels than those who received an NVP regimen. ARV-naive children had a better CD4 response than the ARV-experienced. The survival rates of children in the NVP groups were not different from those in the EFV groups for both the ARV-naive and the ARV-experienced. Treatment failure occurred in one ARV-naive NVP case (2.6%), two ARV-naive EFV cases (5.8%), and nine ARV-experienced NVP cases (39%) at 24 months of treatment, and 11 ARV-experienced EFV cases (25%) at 18 months of treatment. Seven (10%) children had adverse effects from treatment with NVP. The main side effects were rash and hepatitis; six had to switch to EFV. Four (5%) children had adverse effects from treatment with EFV; two had to switch to NVP. Conclusions Both NVP- and EFV-based HAART regimens were effective in children in Thailand for at least 3 years. HIV-infected Thai children generally tolerated NNRTI well.

To evaluate the efficacy and safety of short-course therapy with zidovudine plus lamivudine for reduction of perinatal transmission of human immunodeficiency virus type 1 (HIV-1), a single-arm, open-label, prospective, nonrandomized study was conducted. One hundred six treatment-naive pregnant women received zidovudine (300 mg) plus lamivudine (150 mg) twice daily from week 34 of gestation until the onset of labor. During labor, zidovudine and lamivudine were given every 3 h. Neonates received zidovudine syrup for 4 weeks and were bottle fed. The median maternal virus load and CD4 + cell count at weeks 32-34 of gestation were 4.33 log 10 copies/mL and 274 cells/mm 3 , respectively. At delivery, the mothers' mean decrease in virus load was 1.55 log 10 copies/mL and the mean increase in CD4 + cell count was 93 cells/mm 3 , compared with enrollment levels. Three neonates were HIV-1 infected, for a transmission rate of 2.83% (95% confidence interval, 1%-8%). There were no serious adverse events in the mothers. Adverse events noted in neonates were anemia (in 6 neonates), elevated transaminase levels (in 1), and thrombocytopenia (in 3). Short-course therapy with zidovudine plus lamivudine appeared to be safe and effective for prevention of perinatal transmission of HIV-1.

Human immunodeficiency virus (HIV) levels in cervicovaginal lavage (CVL) and plasma samples were evaluated in relation to perinatal transmission in a randomized placebo-controlled trial of brief antenatal zidovudine treatment. Samples were collected at 38 weeks' gestation from 310 women and more frequently from a subset of 74 women. At 38 weeks, after a 2-week treatment period, CVL HIV-1 was quantifiable in 23% and 52% of samples in the zidovudine and placebo groups, respectively (P 10,000 copies/mL) and 1% among women without quantifiable CVL HIV-1 and with low plasma virus levels (P

To determine the rate and risk factors for human immunodeficiency virus (HIV)-1 subtype E perinatal transmission, with focus on virus load, pregnant HIV-infected women and their formula-fed infants were followed prospectively in Bangkok. Of 281 infants with known outcome, 68 were infected (transmission rate, 24.2%; 95% confidence interval, 19.3%-29.6%). Transmitting mothers had a 4.3-fold higher median plasma HIV RNA level at delivery than did nontransmitters (P 10,000 copies/mL. Although risk is multifactorial, high maternal virus load at delivery strongly predicts transmission. This may have important implications for interventions designed to reduce perinatal transmission.

Summary Background Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of short-course oral zidovudine administered during late pregnancy and labour. Methods In a randomised, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR. Findings Between May, 1996, and December, 1997, 397 women were enrolled; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9·4% (95% CI 5·2–13·5) on zidovudine and 18·9% (13·2–24·2) on placebo (p=0·006; efficacy 50% [15·4–70·6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0·56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery. Interpretation A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen.

Background. A knowledge of the epidemiology of Pneumocystis carinii pneumonia (PCP) is important for the development of a strategy for primary PCP prophylaxis and empiric treatment for severe pneumonia in HIV-infected children. However, little is known about the epidemiology of PCP in developing countries. Objective. To measure the relative rate of PCP among hospitalized HIV-infected children with severe pneumonia in Bangkok and evaluate the effect of a strategy of primary PCP prophylaxis in HIV-exposed infants. Methods. All HIV-infected children hospitalized from January, 1996, to December, 1997, for severe pneumonia were investigated for PCP with the use of specimens obtained from bronchoalveolar lavage, endotracheal aspiration or lung tissue necropsy. Characteristics associated with severe pneumonia were described, and the differences between PCP and non-PCP in these severely ill children were analyzed. In June, 1996, a strategy of primary PCP prophylaxis using trimethoprim-sulfamethoxazole in all HIV-exposed infants from 1 to 6 month of age was initiated in our institution. The effect of this strategy was evaluated. Results. Of 279 hospitalized HIV-infected children 128 (46%) were diagnosed with pneumonia and 26 (20%) of these had severe pneumonia. P. carinii was identified in 9 (35%) children with severe pneumonia. After June, 1996, the rate of severe pneumonia among all hospitalized children decreased from 16% from January through June, 1996, to 7% from July, 1996, through December, 1997 (P = 0.02). Cases of PCP decreased from 9 in 1996 to zero in 1997. The percentage of HIV-infected children receiving PCP prophylaxis at the time of admission increased from 53% before June, 1996, to 72% in late 1997 (P = 0.04). The overall percentage of patients with severe pneumonia receiving PCP prophylaxis at the time of admission was 34%. Breakthrough PCP occurred in 2 children with poor compliance. Patients with PCP were significantly younger than those without PCP (mean age, 10.6 ± 10.6 vs. 29.8 ± 28.3 months, P = 0.02). Conclusion. PCP occurred in one-third of cases of severe pneumonia in HIV-infected children in Bangkok. The data suggest that PCP prophylaxis can prevent both PCP and non-PCP.

To elucidate genetic characteristics of HIV-1 subtype E involved in vertical transmission, V3 regions of HIV-1 subtype E isolated from 17 infected mothers (M1-M17) and their infants (I1-I17) at 1 month after birth were sequenced after cloned into pCRII vectors. At least three clones of each sample were collected. All mothers were asymptomatic and had been infected through a heterosexual route. Nine infants (I9-I17) showed mild symptomatic and immunosuppression within the first year of life. The interpatient nucleotide distance of mothers and infants in this group (0.065+/-0.008) were of greater diversity than those of a nonimmunosuppression group (0.039+/-0.006) by a significant amount (Fischer's exact test, p = .003). The substitution with asparagine (N) at threonine (T) at position 13 and aspartic acid (D) at position 29 of the V3 sequence were significantly associated with nonimmunosuppression in the first year of life (F-test, p = 0.003). Either a single or multiple viral variants could transmit from mothers to their infants.At least 1.5 million children worldwide are infected with HIV-1. Most HIV-infected children obtained the virus from their mother either in utero, at delivery, or postpartum through breast-feeding. Since the V3 loop of HIV is an important determinant for viral neutralization and cellular tropism, mutations in the V3 region could possibly affect mother-to-child transmission. Serum specimens from 17 HIV-1-seropositive mother-child pairs being treated at the pediatric clinic of Siriraj Hospital, Bangkok, in 1994 and 1995, were studied to better understand the genetic characteristics of HIV-1 subtype E involved in vertical transmission. The V3 regions of HIV-1 subtype E isolated from the subjects at 1 month after birth were sequenced after being cloned into pCRII vectors, with at least 3 clones of each sample collected. All mothers were asymptomatic and had been infected through a heterosexual route. 9 infants were mildly symptomatic and had evidence of immunosuppression during their first year of life. The nucleotide sequences of asymptomatic infants were significantly closer to maternal sequences than those of the AIDS cases. The data suggest that 1 or 2 genotypes from the mother were selected, transmitted to the infant, and then became diverse. The substitution with asparagine at threonine at position 13 and aspartic acid at position 29 of the V3 sequence were significantly associated with nonimmunosuppression during the first year of life.

The objective of this study was to assess changes in the family situation of HIV-infected women who have recently given birth. As part of a prospective perinatal HIV transmission study, interviews were conducted with a subset of HIV-infected women at 18 to 24 months postpartum, and answers were compared with baseline information obtained during pregnancy. Standardized scales were used to assess levels of psychosocial functioning. A convenience sample of 129 HIV-infected women enrolled during pregnancy was interviewed at 18 to 24 months postpartum. At delivery, the women were young (median age, 22 years), primiparous (57%), and asymptomatic (93%). When baseline and follow-up data were compared, more women were living alone (1% versus 6%; p = 0.03), fewer women were living with their partners (98% versus 73%; p0.001), and 30% of families had reduced incomes. At follow-up, 10% of partners had died, and more partners than wives had become ill or died (21% versus 4%; p = 0.02). Most children (78%) were living with their mothers, but only 57% of the HIV-infected women were the primary caretakers. Fewer women had disclosed their HIV status to others (e.g., family, friends) than to their partners (34% versus 84%; p0.001), largely because of fear of disclosure. The women appeared to have high levels of depression and worry. The women's greatest worries were about their children's health and the family's future. Within 2 years after childbirth, substantial change within the families of HIV-infected women was evident. These were manifest by partner illness or death, family separation, reduced family income, shifting responsibilities for child care, and signs of depression and isolation. Providing family support is a major challenge in Thailand as the perinatal HIV epidemic progresses.As part of a larger prospective perinatal HIV transmission study in Bangkok, Thailand (1992-94), interviews were conducted with a subset of 129 HIV-infected women 18-24 months after delivery and the results were compared with data obtained from these women during pregnancy. The median age of women at delivery was 22 years; 57% were primiparous and 93% were asymptomatic at delivery. 25 infants (19.4%) had confirmed HIV infection and 2 had died by the time of the follow-up interview. By follow up, 21% of male partners had died or developed HIV-related functional impairments. The proportion of women living alone rose from 1% at baseline to 6% at follow up, while the proportion living with their partner declined from 98% to 73%. 30% of families had reduced incomes at follow-up compared with baseline. Although 78% of infants were living with their mothers, they were the primary caretakers in only 57% of families. Only 34% of HIV-infected mothers had disclosed their HIV status to friends or family other than their partner. 43% of women scored above the cut-off on the depression scale. Mothers worried extensively about their child's health and their family's future. However, only 37% believed they could find someone to talk to about their feelings related to HIV. 58% were interested in joining a support group for women with HIV. These findings of family disruption, reduced family income, shifting responsibilities for child care, depression, and isolation indicate an urgent need for increased social support for HIV-infected mothers in Thailand.

To determine the prevalence and risk factors associated with cervicitis caused by Chlamydia trachomatis and Neisseria gonorrhoeae in human immunodeficiency virus (HIV) type 1-seropositive and HIV-seronegative pregnant women in Bangkok, and the relation to perinatal HIV transmission.As part of a multicenter perinatal HIV transmission study in an antenatal population with 2% HIV seroprevalence, endocervical swabs obtained at mid-pregnancy from a consecutive sample of 222 HIV-seropositive and 219 HIV-seronegative pregnant women at two large hospitals in Bangkok were tested for the presence of C. trachomatis and N. gonorrhoeae by DNA hybridization probe (Gen-Probe). Clinical risk factors and DNA probe results were analyzed in relation to the women's and newborns' HIV infection status.The prevalence of C. trachomatis was 16.2% in HIV-seropositive pregnant women and 9.1% in HIV-seronegative pregnant women (P = 0.03). The prevalence of N. gonorrhoeae was 2.7% in HIV-seropositive pregnant women and 1.4% in HIV-seronegative pregnant women (P = 0.5). The overall population prevalence estimate was 9.2% for C. trachomatis and 1.4% for N. gonorrhoeae. Women with gonococcal infection were more likely to be positive for C. trachomatis (RR(MH) = 5.2, P0.01). Young age (21 years) and primigravid status were associated with C. trachomatis infection among HIV-seropositive women; history of multiple sex partners (1) were associated with C. trachomatis infection among HIV-seronegative women. For HIV-seropositive women, primigravida status also was associated with C. trachomatis infection. The perinatal HIV transmission rates were similar for those with and without C. trachomatis (24.1% and 23.2%, P = 0.9) and among those with and without N. gonorrhoeae (20% and 23.5%, P = 1.0).Among pregnant women in Bangkok, C. trachomatis infection was considerably more common than N. gonorrhoeae infection and was associated with HIV infection, young age and first pregnancy (HIV-seropositive women), and multiple partners (HIV-seronegative women). Our data do not suggest an association between perinatal HIV transmission and maternal C. trachomatis or N. gonorrhoeae infection identified and treated during pregnancy. The high prevalence of C. trachomatis found using a test not readily available in Thailand emphasizes the need for improved, inexpensive ways to screen for and diagnose these sexually transmitted infections in developing countries.Numerous studies have suggested that Chlamydia trachomatis and Neisseria gonorrhoeae facilitate heterosexual HIV transmission; the impact of these sexually transmitted diseases (STDs) on perinatal HIV transmission is unknown, however, due to the expense of routine screening for STDs during pregnancy in developing countries. As part of a multicenter perinatal HIV transmission study, 222 HIV-positive and 219 HIV-negative women presenting for prenatal care at 2 hospitals in Bangkok, Thailand, during 1993-94 were enrolled. At mid-pregnancy, endocervical swabs were obtained and tested for the presence of C. trachomatis and N. gonorrhoeae by DNA hybridization probe. There were 36 cases (16.2%) of C. trachomatis infection among HIV-positive women and 20 cases (9.1%) among HIV-negative women. There were 6 cases (2.7%) of N. gonorrhoeae among HIV-positive women and 3 cases (1.4%) among HIV-negative women. Based on an estimated antenatal HIV seroprevalence of 2%, these findings imply a general antenatal prevalence of 9.2% for C. trachomatis and 1.4% for N. gonorrhoeae. Women with gonococcal infection were more likely (relative risk, 5.2) to be positive for C. trachomatis as well. C. trachomatis infection among HIV-infected pregnant women was associated with age under 21 years and primigravidity. The overall perinatal HIV transmission rate was 24.2%, with no significant difference according to STD infection status. However, since all women diagnosed with STDs received treatment by the mid-third trimester of pregnancy, it remains possible that untreated STDs facilitate perinatal HIV transmission. The high prevalence of C. trachomatis detected in this study through use of a test not readily available in Thailand emphasizes the need for inexpensive, reliable methods to screen for STDs among pregnant women in developing countries.

Objective. The purpose of this study was to describe the epidemiology of coinfection with hepatitis C virus (HCV) and HIV among a cohort of pregnant Thai women.Methods. Samples from 1771 pregnant women enrolled in three vertical transmission of HIV studies in Bangkok, Thailand, were tested for HCV.Results. Among HIV-infected pregnant women, HCV seroprevelance was 3.8% and the active HCV infection rate was 3.0%. Among HIV-uninfected pregnant women, 0.3% were HCV-infected. Intravenous drug use by the woman was the factor most strongly associated with HCV seropositivity. Among 48 infants tested for HCV who were born to HIV/HCV coinfected women, two infants were HCV infected for an HCV transmission rate of 4.2% (95% 0.51–14.25%).Conclusions. HCV seroprevalence and perinatal transmission rates were low among this Thai cohort of HIV-infected pregnant women.

Although most of Thai children older than 2 years are immune against Haemophilus influenzae type b (Hib) without prior vaccination, it may not be the case in HIV-infected children. Of 44 HIV-infected children tested before vaccination at the mean age of 36 months (range 24-84 months), 32 (73%) were susceptible (anti-PRP0.15 microg/ml). At 6 months after a single dose of tetanus-conjugated Hib vaccination, 67% developed anti-PRP/=0.15 microg/ml, however, only 33% developed titer of/=1 microg/ml. Four of seven (57%) with anti-PRP 0.15-0.99 microg/ml at baseline were boosted to the titer of/=1 microg/ml after vaccination. Seroconversion rate and geometric mean titer (GMT) level in response to the vaccination did not correlate with HIV stage, but did correlate with viral load level of 100,000 copies/ml. HIV-infected children older than 2 years would benefit from Hib vaccination, although, one dose catch-up schedule is not sufficient in a third of these children. A second dose is needed in these children especially those with viral load of level of100,000 copies/ml.

Objective. To describe survival and signs of human immunodeficiency virus (HIV) infection in perinatally infected children in Thailand.Methods. At 2 large Bangkok hospitals, 295 infants born to HIV-infected mothers were enrolled at birth from November 1992 through September 1994 and followed up with clinical and laboratory evaluations every 1 to 3 months for 18 months. Infected children remained in follow-up thereafter. For the infected children, we used data collected through October 2000 to estimate survival times and compare characteristics among those whose disease progressed at rapid (died within 1 year), intermediate (died at 1–5 years), and slow (survived at least 5 years) rates.Results. None of the 213 uninfected children died during the follow-up period. Of the 68 infected children, 31 (46%) died; median survival was 60 months (95% confidence interval: 31–89 months). The most common cause of death was pneumonia (52% of deaths). Thirty-two children (47%) started antiretroviral therapy. Six children died in their first year before developing specific signs of HIV infection; all others developed signs of HIV infection between 1 and 42 months old (median: 4 months). Severe clinical (Centers for Disease Control and Prevention Class C) conditions were diagnosed in 23 children at a median age of 12 months, 15 (65%) of whom died a median of 3 months later. Compared with children whose disease progressed slowly, those whose disease progressed rapidly gained less weight by 4 months old (median 1.7 vs 2.6 kg), and their mothers had higher viral loads (median 5.1 vs 4.5 log10 copies/mL) and lower CD4+ counts (median 350 vs 470 cells/μL) at delivery.Conclusions. Among HIV-infected Thai children, survival times are longer than among children in many African countries, but shorter than among children in the United States and Europe. Signs of HIV develop early in most children. Growth failure and advanced maternal disease can predict rapid HIV disease progression and may be useful markers for treatment decisions.

Shaffer et al. reported that in a randomized placebo-controlled trial in Thailand a short course of antenatal zidovudine administered from 36 weeks gestation until delivery reduced perinatal HIV-1 transmission by 50%. However while this course reduced perinatal HIV-1 transmission by 50% and the level of presumed intrapartum transmission by 61% in-utero transmission was reduced by only 29%. The overall reduction in transmission in the Pediatric AIDS Clinical Trials Group (PACTG) protocol 076 was 68% with similarly significant presumed reductions in intrapartum and in-utero HIV transmission. Shaffer et al. reported a greater net reduction in plasma HIV-1 RNA load from entry to delivery compared with PACTG 076. The authors found no clear evidence of a larger early decrease in RNA on the basis of an analysis of median change in plasma HIV RNA loads according to quartile of treatment duration. Finally the 2 studies differed in the estimated proportion of zidovudine treatment effect (PTE) explained by maternal plasma HIV-1 RNA load at delivery which was 80% in the Thai study and 11% in PACTG 076. Insufficient data were available with which to calculate PTE according to treatment duration. The full PACTG 076 zidovudine regimen should continue to be recommended for prophylaxis of perinatal HIV-1 transmission in countries capable of implementing it.

Context.—Most prior studies of the human immunodeficiency virus (HIV) epidemic in Thailand have focused on commercial sex encounters; however, because the epidemic increasingly concerns stable heterosexual relationships, determining risk factors for this form of transmission is warranted.Objectives.—To determine temporal trends in HIV prevalence, risk factors for HIV seropositivity, and rates of partner serodiscordance for pregnant women in Bangkok, Thailand.Design.—Retrospective review of hospital antenatal clinic HIV test results from 1991 through 1996. Baseline demographic and behavioral risk factors for HIV were assessed for subjects enrolled from November 1992 through March 1994.Setting.—Two Bangkok hospitals with routine antenatal clinic HIV counseling and testing.Participants.—The HIV-positive pregnant women enrolled in a perinatal HIV transmission study and their partners and HIV-negative pregnant controls.Results.—From 1991 through 1996, antenatal clinic HIV seroprevalence increased from 1.0% to 2.3%. On multivariate analysis of data from 342 HIV-positive and 344 HIV-negative pregnant women, more than 1 lifetime sex partner, history of a sexually transmitted disease, and a high-risk sex partner were the most important factors for seropositivity (all P

The protective effect of bacille Calmette-Guérin (BCG) vaccination against tuberculosis is controversial. In a study, 330 patients less than 12 years of age with tuberculosis, 52.1% of whom had had BCG vaccination, were compared with a control group of 1106 patients free of tuberculosis, 81% of whom had BCG vaccination. The occurrence of disseminated forms of tuberculosis, tuberculous meningitis, tuberculous peritonitis, and tuberculosis of bone and joints in BCG-vaccinated patients was quite low. With BCG vaccination, the incidence of the disseminated form of tuberculosis was significantly lower than that of pulmonary tuberculosis with pulmonary parenchymal lesions, primary pulmonary complexes, and pleural effusion. Tuberculous peritonitis was significantly less frequent than pulmonary tuberculosis with pulmonary parenchymal lesions, enlarged hilar glands, pulmonary primary complex, and pleural effusions. The study demonstrated that BCG gave an overall protective effect of 74% and that a major effect of this immunity was to produce a localized form of tuberculosis.