38 results on '"Deyton, L."'
Search Results
2. The immunology case registry
- Author
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Backus, L, Mole, L, Chang, S, and Deyton, L
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- 2001
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3. Zidovudine, didanosine, and zalcitabine in the treatment of HIV infection: meta-analyses of the randomised evidence. HIV Trialists' Collaborative Group
- Author
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Abrams, D, Allan, D, Antunes, F, Breckenridge, A, Bruun, J, Cameron, W, Carbon, C, Chalmers, I, Chang, H, Chodakewitz, J, Clendenin, N, Clumeck, N, Collier, A, Collins, G, Cooper, E, Cooper, D, Danner, S, D'Aquila, R, DeGruttola, V, DeMasi, R, Dee, L, Deyton, L, Dixon, D, Farthing, C, and Feinberg, J
- Abstract
BACKGROUND: To assess the effects of zidovudine, didanosine, and zalcitabine on HIV disease progression and survival, we undertook meta-analyses of individual patient data and tabular data from all randomised trials that compared these agents. METHODS: Individual patient data were available for 7722 participants without AIDS in the nine randomised trials of immediate versus deferred zidovudine, and 7700 participants with or without AIDS in the six trials comparing zidovudine plus didanosine, zidovudine plus zalcitabine, or zidovudine alone. The main outcomes were mortality and disease progression (new AIDS-defining event or death before any such event). FINDINGS: In the comparison of immediate versus deferred zidovudine, during a median follow-up of 50 months, 1908 individuals progressed, of whom 1351 died. In the deferred group, 61% started antiretroviral therapy (median time to therapy 28 months, which was zidovudine monotherapy in 94%). During the first year of follow-up, immediate zidovudine halved the rate of disease progression (p
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- 2016
- Full Text
- View/download PDF
4. Zidovudine, didanosine, and zalcitabine in the treatment of HIV infection: meta-analyses of the randomised evidence. HIV Trialists' Collaborative Group
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Abrams, D, Allan, D, Antunes, F, Breckenridge, A, Bruun, J, Cameron, W, Carbon, C, Chalmers, I, Chang, H, Chodakewitz, J, Clendenin, N, Clumeck, N, Collier, A, Collins, G, Cooper, E, Cooper, D, Danner, S, D'Aquila, R, DeGruttola, V, DeMasi, R, Dee, L, Deyton, L, Dixon, D, Farthing, C, Feinberg, J, Fischl, M, Flepp, M, Gartland, M, Gatell, J, Gazzard, B, Goebel, F, Gotzsche, P, Gringeri, A, Hall, D, Hamilton, J, Hammer, S, Hartigan, P, Heath-Chiozzi, M, Henry, K, Hill, A, Hirschel, B, Ioannidis, J, Kahn, J, Katlama, C, Katzenstein, D, Killen, J, King, E, de Loes, SK, Kravcik, S, Lange, J, Leavitt, R, Leonard, J, Maeland, A, Mannucci, P, Mathiesen, L, McDade, H, Meibohn, A, Melander, H, Merigan, T, Mulder, J, Myers, M, Neaton, J, Nessling, M, Perrin, L, Pettinelli, C, Phair, J, Phillips, A, Pinching, A, Poppa, A, Power, L, Reiss, P, Richman, D, Rooney, J, Rousseau, F, Rutherford, G, Salgo, M, Sandstrom, E, Saravolatz, L, Savidge, G, Schnittman, S, Schooley, R, Seligmann, M, Simberkoff, M, Skowron, G, Slade, P, Smith, D, Smith, RP, Soriano, V, Stanley, K, Stingl, G, Stoffels, P, Struthers, L, Tierney, C, Thompson, M, Van der Broeck, R, Van Leeuven, R, Van Weverling, G, Veenstra, J, Vella, S, Volberding, P, Weber, J, Winslow, D, Yeni, P, Yeo, J, Dormont, J, Sande, M, Weller, I, Babiker, A, Collins, R, Darbyshire, J, Duncan, W, Foulkes, M, Hughes, M, Peto, R, Peto, T, Walker, S, and Grp, HIVTC
- Abstract
BACKGROUND: To assess the effects of zidovudine, didanosine, and zalcitabine on HIV disease progression and survival, we undertook meta-analyses of individual patient data and tabular data from all randomised trials that compared these agents. METHODS: Individual patient data were available for 7722 participants without AIDS in the nine randomised trials of immediate versus deferred zidovudine, and 7700 participants with or without AIDS in the six trials comparing zidovudine plus didanosine, zidovudine plus zalcitabine, or zidovudine alone. The main outcomes were mortality and disease progression (new AIDS-defining event or death before any such event). FINDINGS: In the comparison of immediate versus deferred zidovudine, during a median follow-up of 50 months, 1908 individuals progressed, of whom 1351 died. In the deferred group, 61% started antiretroviral therapy (median time to therapy 28 months, which was zidovudine monotherapy in 94%). During the first year of follow-up, immediate zidovudine halved the rate of disease progression (p
- Published
- 1999
5. Importance of surrogate markers in evaluation of antiviral therapy for HIV infection
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Deyton, L., primary
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- 1996
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6. Toxicity of clindamycin as prophylaxis for AIDS-associated toxoplasmic encephalitis
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Jacobson, M.A, primary, Child, C, additional, Besch, C.L, additional, Hafner, R, additional, Deyton, L, additional, Matts, J.P, additional, Wentworth, D.N, additional, and Muth, K, additional
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- 1992
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7. CDC Grand Rounds: Current Opportunities in Tobacco Control.
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Tynan, M., Pechacek, T., McKenna, M., Ashley, D., Deyton, L., and Popovic, T.
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SMOKING prevention ,TOBACCO products ,PUBLIC health ,WORLD health - Abstract
The article discusses measures undertaken by the World Health Organization (WHO) to lessen the prevalence of smoking worldwide. It mentions the WHO Framework Convention on Tobacco Control (FCTC) treaty which was formed to protect the public's health by adopting measures to reduce the demand for tobacco. These measures include the move to increase the prices of tobacco products, prevention of exposure to smoke and public awareness on the health risks associated with tobacco smoking.
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- 2010
8. War, its aftermath, and U.S. health policy: toward a comprehensive health program for America's military personnel, veterans, and their families.
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Jackonis MJ, Deyton L, and Hess WJ
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This essay discusses the challenges faced by veterans returning to society in light of the current organization and structure of the military, veterans', and overall U.S. health care systems. It also addresses the need for an integrated health care financing and delivery system to ensure a continuum of care for service members, veterans, dependents, and other family members. The health care systems of both the Department of Defense and the Department of Veterans Affairs execute their responsibilities to active duty service members, while their families and retirees/veterans are under separate legal authorities. Although they perform their mandates with extraordinary commitment and demonstrably high quality, both systems need to explore improved communication, coordination, and sharing, as well as increased collaboration with the Department of Health and Human Services programs serving the same populations, far beyond current efforts. The health care-related missions and the locus of health care delivery of each agency are admittedly unique, but their distinctions must not be permitted to impede system integration and coordination of a continuum of care provided to the men and women who serve the nation, and their families. [ABSTRACT FROM AUTHOR]
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- 2008
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9. Community Planning for Pandemic Influenza: Lessons From the VA Health Care System.
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Lurie N, Dausey DJ, Knighton T, Moore M, Zakowski S, and Deyton L
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- 2008
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10. Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee.
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Bozzette, S A, Phillips, B, Asch, S, Gifford, A L, Lenert, L, Menke, T, Ortiz, E, Owens, D, and Deyton, L
- Published
- 2000
11. Combined zidovudine and interferon-alpha therapy in patients with Kaposi sarcoma and the acquired immunodeficiency syndrome (AIDS)
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Kovacs, J A, Deyton, L, Davey, R, Falloon, J, Zunich, K, Lee, D, Metcalf, J A, Bigley, J W, Sawyer, L A, and Zoon, K C
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AIDS treatment , *THERAPEUTIC use of interferons , *AIDS , *AZIDOTHYMIDINE , *COMBINED modality therapy , *DOSE-effect relationship in pharmacology , *INTERFERONS , *KAPOSI'S sarcoma , *LEUKOCYTE count , *DISEASE complications - Abstract
Study Objective: To evaluate the toxicity and potential clinical efficacy of combined therapy with zidovudine and interferon-alpha for patients with Kaposi sarcoma and the acquired immunodeficiency syndrome (AIDS).Design: Nonrandomized, open trial study.Setting: Outpatient clinic of a government referral-based research hospital.Patients: Volunteer sample of 39 patients with human immunodeficiency virus (HIV) infection and Kaposi sarcoma.Interventions: Patients received zidovudine, 250, 100, or 50 mg orally every 4 hours; 6 weeks after interferon-alpha was begun at a dose of 5 million U/d, and the dose was increased every 2 weeks until a maximum tolerated dose was determined. Patients then received the maximum tolerated dose of the combination for a minimum of 12 weeks before formal efficacy evaluations.Measurements and Main Results: In the dose-escalation phase, the ability to tolerate interferon-alpha was clearly related to the zidovudine dose. Of the 13 patients receiving 250 mg of zidovudine, only 1 patient was able to tolerate at least 10 million U/d of interferon-alpha. Of the 12 patients receiving 100 mg of zidovudine, 8 tolerated 10 million U/d, 5 tolerated 15 million U/d, and none tolerated higher doses. Of the 12 patients receiving 50 mg of zidovudine, 8 tolerated 10 million U/d, 7 tolerated 15 million U/d, and 6 tolerated 20 million U/d or more. Dose-limiting toxicities included neutropenia (57%), fatigue (16%), thrombocytopenia (14%), and hepatic dysfunction (10%). Of the 22 patients who received a stable dose of both drugs for 12 weeks, 11 patients had a complete or partial tumor response and 8 showed an anti-HIV effect. Peak serum levels of interferon-alpha (32 to 250 U/mL) and zidovudine (0.40 to 3.85 microM) were in the ranges previously shown to be synergistic against HIV.Conclusions: Combination therapy with zidovudine and interferon-alpha can be administered to patients with HIV infection and Kaposi sarcoma in doses that effect antiviral and antitumor responses; it appears to have a potential role in managing such patients. [ABSTRACT FROM AUTHOR]- Published
- 1989
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12. Clinical programs for clinical research on AIDS: Description of a randomized prospective study of clindamycin versus pyrimethamine for prevention of Toxoplasma gondii infection.
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Jacobson, M., Besch, C., Child, C., Hafner, R., Muth, K., and Deyton, L.
- Abstract
The risk of toxoplasmic encephalitis complicating AIDS appears largely limited to those HIV-infected patients with serologic evidence of past Toxoplasma gondii infection and low CD4 lymphocyte counts. The Community Programs for Clinical Research on AIDS has initiated a randomized, placebo-controlled trial to determine if clindamycin or pyrimethamine prophylactic regimens are effective and safe in preventing toxoplasmic encephalitis. [ABSTRACT FROM AUTHOR]
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- 1991
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13. Interferon-alpha in patients with asymptomatic human immunodeficiency virus (HIV) infection. A randomized, placebo-controlled trial.
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Lane, H C, Davey, V, Kovacs, J A, Feinberg, J, Metcalf, J A, Herpin, B, Walker, R, Deyton, L, Davey, R T Jr, and Falloon, J
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THERAPEUTIC use of interferons ,THERAPEUTIC use of proteins ,HIV infection complications ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,OPPORTUNISTIC infections ,PNEUMOCYSTIS pneumonia ,PROTEINS ,RECOMBINANT proteins ,RESEARCH ,RESEARCH funding ,STATISTICS ,T cells ,EVALUATION research ,BLIND experiment ,ANTI-HIV agents ,LEUKOCYTE count - Abstract
Study Objective: To evaluate the toxicity and clinical efficacy of interferon-alpha 2b (IFN-alpha) in patients with asymptomatic human immunodeficiency virus (HIV) infection.Design: Randomized, placebo-controlled, and double-blind study.Setting: Outpatient clinic of a government referral-based research hospital.Patients: Volunteer sample of 34 patients with asymptomatic HIV infection who had CD4 counts of 400 cells/mm3 or more, positive peripheral blood mononuclear cell cultures for HIV, or p24 antigenemia.Interventions: Patients were randomly assigned to receive either IFN-alpha or placebo, 35 x 10(6) units per day subcutaneously. Doses of IFN-alpha or placebo were modified according to predefined laboratory and clinical criteria. Therapy lasted at least 12 weeks.Measurements and Main Results: Seventeen patients were randomly assigned to each group. The two groups had similar mean CD4 counts at study entry. Thirty-five percent of patients assigned to receive IFN-alpha withdrew from the study because of toxicity. The average daily dose of IFN-alpha was 17.5 x 10(6) units. All patients receiving IFN-alpha reported flu-like symptoms; other toxicities included granulocytopenia (55%) and elevated liver enzyme levels (45%). While receiving IFN-alpha, 7 patients (41%) became HIV culture negative (three or more consecutive negative peripheral blood mononuclear cell cultures taken at least 2 weeks apart). In contrast, 2 patients in the placebo group (13%) became culture negative while on study (P = 0.05). During the treatment period, CD4 lymphocyte percentages were sustained at or above the baseline level in patients receiving IFN-alpha and declined slightly in patients receiving placebo. Of the 32 study patients followed after study (range, 5 to 33 months), no patients in the IFN-alpha group developed an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection, compared with 5 patients in the placebo group (P = 0.02).Conclusions: Treatment of early-stage HIV infection with IFN-alpha can result in a decrease in frequency of viral isolation. Although its use may be accompanied by dose-dependent toxicities, IFN-alpha may have a role in slowing progression of HIV disease. [ABSTRACT FROM AUTHOR]- Published
- 1990
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14. Zidovudine in patients with human immunodeficiency virus (HIV) infection and Kaposi sarcoma. A phase II randomized, placebo-controlled trial.
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Lane, H. Clifford, Falloon, Judith, Walker, Robert E., Deyton, Lawrence, Kovacs, Joseph A., Masur, Henry, Banks, Steven, Kirk, L. Edward, Baseler, Michael W., Salzman, Norman P., Fauci, Anthony S., Lane, H C, Falloon, J, Walker, R E, Deyton, L, Kovacs, J A, Masur, H, Banks, S, Kirk, L E, and Baseler, M W
- Subjects
AZIDOTHYMIDINE ,THERAPEUTICS ,HIV infections ,MEDICAL care of HIV-positive persons - Abstract
Study Objective: To evaluate the toxicity, effects on immune function, antitumor effects, antiretroviral effects, and pharmacokinetics of zidovudine therapy in patients with early human immunodeficiency virus (HIV) infection and Kaposi sarcoma.Design: Randomized, double-blind, placebo-controlled trial.Setting: National Institutes of Health, a referral-based research institution (single site).Patients: Physician-referred volunteer patients with HIV infection, Kaposi sarcoma, CD4+ lymphocyte counts greater than 0.2 x 10(9)/L, and no systemic symptoms or history of opportunistic infection. Of 41 patients enrolled, 4 had not met all entry criteria and were therefore not evaluable.Interventions: Patients were randomized to one of four treatment groups for an initial 12-week treatment period: oral placebo (9 patients); zidovudine, 250 mg orally every 4 hours (9 patients); zidovudine, 0.5 mg/kg body weight intravenously every 4 hours (9 patients); and zidovudine, 2.5 mg/kg intravenously every 4 hours (10 patients). After at least 12 weeks of therapy at their assigned dose, patients were treated with oral zidovudine, generally 250 mg every 4 hours, with a mean 42-week follow-up.Measurements and Main Results: Anemia and granulocytopenia were the major toxicities. Significant increases in platelet counts and declines in serum HIV antigen and IgG and IgM levels occurred in treated patients. Treated patients were more likely than those on placebo to clear HIV from the cerebrospinal fluid. There were no differences in tumor progression or CD4+ or CD8+ lymphocyte counts among the groups.Conclusions: Zidovudine was well tolerated and had antiretroviral activity in patients with early HIV infection and Kaposi sarcoma but it had no significant effect on the extent of Kaposi sarcoma or on immune function. [ABSTRACT FROM AUTHOR]- Published
- 1989
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15. Guidelines for preventing opportunistic infections among HIV-infected persons - 2002
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Masur, H., Kaplan, J. E., Holmes, K. K., Alston, B., Alter, M. J., Ampel, N., Anderson, J. R., Baker, A. C., Barr, D., Bartlett, J. G., Bennett, J. E., Benson, C. A., Bower, W. A., Bozzette, S. A., Brooks, J. T., Cargill, V. A., Castro, K. G., Chaisson, R. E., Cooper, D., Crumpacker, C. S., Currier, J. S., Decock, K. M., Deyton, L., Dowell, S. F., Drew, W. L., Duncan, W. R., Dworkin, M. S., Dykewicz, C., Eisinger, R. W., Ellerbrock, T., El-Sadr, W., Feinberg, J., Freedberg, K. A., Keiji Fukuda, Furrer, H., Gatell, J. M., Gnann Jr, J. W., Goldberger, M. J., Goldie, S., Goosby, E. P., Gordin, F., Gross, P. A., Hajjeh, R., Hafner, R., Havlir, D., Holmberg, S., Holtgrave, D. R., Hooton, T. M., Jabs, D. A., Jacobson, M. A., Jaffe, H., Janoff, E., Jones, J., Juranek, D. D., Kitahata, M., Kovacs, J. A., Leport, C., Levin, M. J., Lopez, J. C., Lundgren, J., Marco, M., Mast, E., Mayers, D., Mofenson, L. M., Montaner, J. S. G., Moore, R., Navin, T., Neaton, J., Nelson, C., O Neill, J. F., Palefsky, J., Pau, A., Pellett, P., Phair, J. P., Piscitelli, S., Polis, M. A., Quinn, T. C., Reeves, W. C., Reiss, P., Rimland, D., Schuchat, A., Sears, C. L., Seeff, L., Sepkowitz, K. A., Sherman, K. E., Slama, T. G., Sloand, E. M., Spector, S. A., Stewart, J. A., Thomas, D. L., Uyeki, T. M., Dyke, R. B., Villarino, M. E., Wald, A., Watts, D. H., Wheat, L. J., Williams, P., and Wright Jr, T. C.
16. A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection
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Abrams, D.I., Goldman, A.I., Launer, C., Korvick, J.A., Neaton, J.D., Crane, L.R., Grodesky, M., Wakefield, S., Muth, K., Kornegay, S., Cohn, D.L., Harris, A., Luskinhawk, R., Markowitz, N., Sampson, J.H., Thompson, M., and Deyton, L.
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HIV infection -- Drug therapy ,Didanosine -- Evaluation ,Zalcitabine -- Evaluation - Abstract
SOURCE: New England Journal of Medicine, March 10, 1994;330(10):657-662. According to the authors' abstract of an article published in the New England Journal of Medicine, "Background: Both didanosine and zalcitabine [...]
- Published
- 1994
17. AIDS-related malignant lymphoma: results of prospective treatment trials.
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Gill, P S, primary, Levine, A M, additional, Krailo, M, additional, Rarick, M U, additional, Loureiro, C, additional, Deyton, L, additional, Meyer, P, additional, and Rasheed, S, additional
- Published
- 1987
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18. Results of a randomized open-label comparison trial of ddI and ddC in HIV infected patients who are intolerant of or have failed ZDV therapy; CPCRA 002
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Abrams, D., Goldman, A., Launer, C., Korvick, J., Crane, L., and Deyton, L.
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Didanosine -- Evaluation ,Zalcitabine -- Evaluation ,HIV infection -- Drug therapy - Abstract
AUTHORS: D. Abrams, A. Goldman, C. Launer, J. Korvick, L. Crane and L. Deyton. The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), National Institute of Allergy and [...]
- Published
- 1993
19. Randomized study of clindamycin (C) or pyrimethamine (P). Prophylaxis fr toxoplasmic encephalitis (TE) in patients with advanced HIV disease
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Jacobson, M.A., Besch, C.L., Child, C., Hafner, R., Matts, J.P., Muth, K., Wentworth, D.N., and Deyton, L.
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Antibacterial agents -- Testing ,Encephalitis -- Drug therapy ,Toxoplasmosis -- Drug therapy ,HIV infection -- Complications ,Clindamycin -- Health aspects ,Pyrimethamine -- Health aspects - Abstract
AUTHORS: M.A. Jacobson, C.L. Besch, C. Child, R. Hafner, J.P. Matts, K. Muth, D.N. Wentworth, L. Deyton, and The Community Programs for Clinical Research on AIDS. University of California, San [...]
- Published
- 1991
20. Community-based HIV trials are rigorous, says NIH.
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Foulkes, M A, Deyton, L R, and Ellenberg, S S
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CLINICAL trials , *HIV infections - Published
- 1993
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21. Digital necrosis and disseminated Pneumocystis carinii infection after aerosolized pentamidine prophylaxis.
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Davey Jr., Richard T., Margolis, David, Kleiner, David, Deyton, Lawrence, Travis, William, Davey, R T Jr, Margolis, D, Kleiner, D, Deyton, L, and Travis, W
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PNEUMOCYSTIS pneumonia ,HIV infections ,THERAPEUTICS ,AIDS treatment ,AEROSOL therapy ,AEROSOLS ,AIDS ,FUNGI ,MYCOSES ,NECROSIS ,TOES ,DISEASE relapse ,PENTAMIDINE ,DISEASE complications - Abstract
Presents cases of patients who developed Pneumocystis carinii pneumonia following aerosolized pentamidine prophylaxis for HIV/AIDS treatment. Medical background of the patients; Treatment administered to the patients; Benefits from aerosolized pentamidine.
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- 1989
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22. Discovering the Roots: A Qualitative Analysis of Medical Students Exploring Their Unconscious Obesity Bias.
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Essel KD, Fotang J, Deyton L, and Cotter EW
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- Humans, Bias, Implicit, Prejudice, Obesity, Students, Medical, Weight Prejudice
- Abstract
Phenomenon: Bias against individuals with obesity in medical settings has negative implications for patients, including stigmatization, poor health outcomes, and reduced healthcare utilization. This study explored reflections of medical students when confronted with their own implicit obesity bias. Approach: A group of 188 pre-clinical second-year medical students from George Washington University School of Medicine and Health Sciences completed the Weight Implicit Association Test (IAT) in 2020 and were instructed to write a reflective response based on their results. Participants reflected upon their preferences ("fat" vs. "thin") and described the factors that influenced their perceptions of obesity. Inductive coding techniques were used to generate themes from medical students' responses using Dedoose Version 8.3.35 (SocioCultural Research Consultants LLC, Los Angeles, California). Findings: Regarding IAT results, 7% of medical students preferred "fat over thin," 14% had no preference, and 78% preferred "thin over fat." Reflection themes highlighted medical students' difficulty accepting IAT results, perspectives on the origins of obesity in individuals, personal and family challenges with obesity and body image, medical training's perceived influence on bias, reservations about discussing obesity with patients, and desires to change current and future practices. Insights: Many medical students expressed a desire to provide optimal care for patients of all weight classes despite demonstrating a strong unconscious bias against individuals with obesity on the IAT. Medical school should provide targeted opportunities to acknowledge and mitigate obesity bias by expanding on medical students' pre-established and often harmful understandings of obesity and highlighting the complexities of this disease. Such training would better equip medical students to facilitate successful interactions with patients as future physicians.
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- 2023
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23. Teaching Trauma-Informed Care: A Symposium for Medical Students.
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Chokshi B, Walsh K, Dooley D, Falusi O, Deyton L, and Beers L
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- Humans, Knowledge, Clinical Clerkship, Students, Medical
- Abstract
Introduction: A large body of evidence links exposure to childhood trauma with negative health outcomes. Training future physicians to recognize and respond to trauma is paramount, and engaging medical students in the preclinical years affords the opportunity to foster the development of a trauma-informed lens that can then be solidified during clinical clerkships., Methods: We developed and implemented a 4-hour trauma-informed care (TIC) symposium for 179 second-year medical students at the George Washington University School of Medicine and Health Sciences during the Patients, Populations, and Systems course. The symposium included three interactive didactic sessions focusing on the connection between trauma and health and TIC principles. A facilitated small-group discussion allowed students to apply TIC principles to a patient case, followed by reflection and evaluation., Results: The overall rating of the TIC symposium was 4 out of 5. Strengths included integration of a small-group case with discussion on application of TIC in practice, experience of the lecturers and small-group facilitators, and review of research relating adversity to specific health outcomes. Suggestions for improvement included incorporating role-play and standardized patients. Content analysis of student reflections mapped to the domains of physician competency., Discussion: A 4-hour symposium can affect student knowledge and understanding of TIC. Teaching TIC presents an opportunity to prepare medical students for a career in medicine through cultivation of required physician competencies. Next steps include enhanced opportunities to practice TIC and follow-up analysis of participants to determine behavior change during clinical years., (© 2020 Chokshi et al.)
- Published
- 2020
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24. Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes.
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Sarma ND, Waye A, ElSohly MA, Brown PN, Elzinga S, Johnson HE, Marles RJ, Melanson JE, Russo E, Deyton L, Hudalla C, Vrdoljak GA, Wurzer JH, Khan IA, Kim NC, and Giancaspro GI
- Subjects
- Cannabinoids chemistry, Hallucinogens chemistry, Hallucinogens metabolism, Humans, Inflorescence chemistry, Cannabidiol chemistry, Cannabinoids analysis, Cannabis chemistry, Dronabinol chemistry
- Abstract
There is an active and growing interest in cannabis female inflorescence ( Cannabis sativa ) for medical purposes. Therefore, a definition of its quality attributes can help mitigate public health risks associated with contaminated, substandard, or adulterated products and support sound and reproducible basic and clinical research. As cannabis is a heterogeneous matrix that can contain a complex secondary metabolome with an uneven distribution of constituents, ensuring its quality requires appropriate sampling procedures and a suite of tests, analytical procedures, and acceptance criteria to define the identity, content of constituents (e.g., cannabinoids), and limits on contaminants. As an independent science-based public health organization, United States Pharmacopeia (USP) has formed a Cannabis Expert Panel, which has evaluated specifications necessary to define key cannabis quality attributes. The consensus within the expert panel was that these specifications should differentiate between cannabis chemotypes. Based on the secondary metabolite profiles, the expert panel has suggested adoption of three broad categories of cannabis. These three main chemotypes have been identified as useful for labeling based on the following cannabinoid constituents: (1) tetrahydrocannabinol (THC)-dominant chemotype; (2) intermediate chemotype with both THC and cannabidiol (CBD); and (3) CBD-dominant chemotype. Cannabis plants in each of these chemotypes may be further subcategorized based on the content of other cannabinoids and/or mono- and sesquiterpene profiles. Morphological and chromatographic tests are presented for the identification and quantitative determination of critical constituents. Limits for contaminants including pesticide residues, microbial levels, mycotoxins, and elemental contaminants are presented based on toxicological considerations and aligned with the existing USP procedures for general tests and assays. The principles outlined in this review should be able to be used as the basis of public quality specifications for cannabis inflorescence, which are needed for public health protection and to facilitate scientific research on cannabis safety and therapeutic potential.
- Published
- 2020
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25. Results of antiretroviral treatment interruption and intensification in advanced multi-drug resistant HIV infection from the OPTIMA trial.
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Holodniy M, Brown ST, Cameron DW, Kyriakides TC, Angus B, Babiker A, Singer J, Owens DK, Anis A, Goodall R, Hudson F, Piaseczny M, Russo J, Schechter M, Deyton L, and Darbyshire J
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- Adult, Drug Resistance, Multiple, Viral, Female, Humans, Male, Middle Aged, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Abstract
Background: Guidance is needed on best medical management for advanced HIV disease with multidrug resistance (MDR) and limited retreatment options. We assessed two novel antiretroviral (ARV) treatment approaches in this setting., Methods and Findings: We conducted a 2×2 factorial randomized open label controlled trial in patients with a CD4 count≤300 cells/µl who had ARV treatment (ART) failure requiring retreatment, to two options (a) re-treatment with either standard (≤4 ARVs) or intensive (≥5 ARVs) ART and b) either treatment starting immediately or after a 12-week monitored ART interruption. Primary outcome was time to developing a first AIDS-defining event (ADE) or death from any cause. Analysis was by intention to treat. From 2001 to 2006, 368 patients were randomized. At baseline, mean age was 48 years, 2% were women, median CD4 count was 106/µl, mean viral load was 4.74 log(10) copies/ml, and 59% had a prior AIDS diagnosis. Median follow-up was 4.0 years in 1249 person-years of observation. There were no statistically significant differences in the primary composite outcome of ADE or death between re-treatment options of standard versus intensive ART (hazard ratio 1.17; CI 0.86-1.59), or between immediate retreatment initiation versus interruption before re-treatment (hazard ratio 0.93; CI 0.68-1.30), or in the rate of non-HIV associated serious adverse events between re-treatment options., Conclusions: We did not observe clinical benefit or harm assessed by the primary outcome in this largest and longest trial exploring both ART interruption and intensification in advanced MDR HIV infection with poor retreatment options., Trial Registration: Clinicaltrials.gov NCT00050089.
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- 2011
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26. Tobacco product regulation--a public health approach.
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Deyton L, Sharfstein J, and Hamburg M
- Subjects
- History, 20th Century, Humans, Marketing legislation & jurisprudence, Smoking adverse effects, Smoking legislation & jurisprudence, Smoking mortality, United States, Tobacco Products, Government Regulation history, Public Health legislation & jurisprudence, Smoking Prevention, Tobacco Industry legislation & jurisprudence, United States Food and Drug Administration history
- Published
- 2010
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27. Relationship between antiretroviral prescribing patterns and treatment guidelines in treatment-naive HIV-1-infected US veterans (1992-2004).
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Holodniy M, Hornberger J, Rapoport D, Robertus K, MaCurdy TE, Lopez J, Volberding P, and Deyton L
- Subjects
- Adolescent, Adult, Aged, Cohort Studies, Female, Humans, Male, Middle Aged, Practice Guidelines as Topic standards, Retrospective Studies, Treatment Outcome, United States, Veterans, Antiretroviral Therapy, Highly Active, Guideline Adherence, HIV Infections drug therapy, Professional Practice standards
- Abstract
Objective: To analyze temporal patterns of antiretroviral (ARV) prescribing practices relative to nationally defined guidelines in treatment-naive patients with HIV-1 infection., Design: Retrospective cohort study., Methods: We evaluated ARV prescribing patterns among ARV treatment-naive veterans who were receiving care within the US Department of Veterans Affairs (VA) from 1992 through 2004 in comparison to evolving adult HIV-1 treatment guidelines., Results: A total of 15,934 patients initiated ARV treatment. Since 1999, >94% of patients initiated at least a 3-ARV medication combination, although the percentage of patients who initiated a guideline "preferred" or "alternative" regimen never rose to greater than 72% and was significantly associated with being black and with region of care. After 1999, 20% of patients started 4 or more active ARV agents in combination, which was significantly associated with lower baseline CD4 cell count, higher viral load, and receiving care in the western United States. The proportion of patients receiving guideline "not recommended" regimens (virologically undesirable or overlapping toxicities) was <1% after 1997. VA prescribing trends generally predated guideline recommendations by 6 to 12 months., Conclusions: VA prescribing patterns for ARV initiation adhere to treatment guidelines that maximize safety. Guidelines designed to maximize efficacy were not followed as stringently. Evaluating clinical practice patterns against contemporary treatment guidelines can inform guideline development.
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- 2007
- Full Text
- View/download PDF
28. Efficacy testing of recombinant human immunodeficiency virus (HIV) gp160 as a therapeutic vaccine in early-stage HIV-1-infected volunteers. rgp160 Phase II Vaccine Investigators.
- Author
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Birx DL, Loomis-Price LD, Aronson N, Brundage J, Davis C, Deyton L, Garner R, Gordin F, Henry D, Holloway W, Kerkering T, Luskin-Hawk R, McNeil J, Michael N, Foster Pierce P, Poretz D, Ratto-Kim S, Renzullo P, Ruiz N, Sitz K, Smith G, Tacket C, Thompson M, Tramont E, Yangco B, Yarrish R, and Redfield RR
- Subjects
- Acquired Immunodeficiency Syndrome immunology, Acquired Immunodeficiency Syndrome virology, Adolescent, Adult, CD4 Lymphocyte Count, Double-Blind Method, Female, HIV Envelope Protein gp160 immunology, Humans, Male, Middle Aged, RNA, Viral analysis, Recombinant Proteins immunology, AIDS Vaccines therapeutic use, Acquired Immunodeficiency Syndrome therapy, HIV-1 immunology, Vaccines, Synthetic therapeutic use
- Abstract
A phase II efficacy trial was conducted with recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein gp160 (rgp160) in 608 HIV-infected, asymptomatic volunteers with CD4+ cell counts >400 cells/mm3. During a 5-year study, volunteers received a 6-shot primary series of immunizations with either rgp160 or placebo over 6 months, followed by booster immunizations every 2 months. Repeated vaccination with rgp160 was safe and persistently immunogenic. Adequate follow-up and acquisition of endpoints allowed for definitive interpretation of the trial results. There was no evidence that rgp160 has efficacy as a therapeutic vaccine in early-stage HIV infection, as measured at primary endpoints (50% decline in CD4+ cell count or disease progression to Walter Reed stage 4, 5, or 6) or secondary endpoints. A transient improvement was seen in the secondary CD4 endpoint for the vaccination compared with the placebo arm, but this did not translate into improved clinical outcome.
- Published
- 2000
- Full Text
- View/download PDF
29. Sex differences in HIV-1 viral load and progression to AIDS.
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Foulkes MA and Deyton L
- Subjects
- Disease Progression, Female, Humans, Male, Sex Factors, Acquired Immunodeficiency Syndrome epidemiology, HIV Infections virology, HIV-1 isolation & purification, Viral Load
- Published
- 1999
- Full Text
- View/download PDF
30. Experience with a cross-study endpoint review committee for AIDS clinical trials. Terry Beirn Community Programs for Clinical Research on AIDS.
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Green LA, Rhame FS, Price RW, Perlman DC, Capps LG, Sampson JH, Deyton LR, Schnittman SM, Fisher EJ, Bartsch GE, Krum EA, and Neaton JD
- Subjects
- AIDS-Related Opportunistic Infections classification, Data Collection methods, Disease Progression, Humans, Clinical Trials as Topic standards, HIV Infections drug therapy, Treatment Outcome
- Abstract
Objectives: To describe the methods and results of a standardized system for clinical endpoint determination for defining and reviewing endpoints in clinical trials for HIV-infected individuals., Design: A system was developed utilizing standard definitions for the 24 diagnoses or clinical events that serve as trial endpoints and together define the combined endpoint 'progression of HIV disease. A common set of case report forms were used for all trials. Thus, an event of Pneumocystis carinii pneumonia (PCP), for example, for a subject co-enrolled in an antiretroviral trial and a PCP prophylaxis trial was only reported once., Methods: A central committee was established to define clinical events and review endpoints across all studies. Events were classified according to established criteria for confirmed, probable and possible levels of certainty., Results: This report describes the methods used to ascertain and review endpoints, and summarized 2299 clinical events for 8097 subjects enrolled in one or more of nine clinical trials. Data on the diagnostic certainty of events and agreement between site clinicians and the endpoint committee are presented., Conclusions: Uniform classification of endpoints across AIDS clinical trials can be accomplished by multicenter, multitrial organizations with standardized definitions and review of endpoint documentation. Our experience suggests that nurse coordinators reviewing all submitted endpoints for every trial are warranted and the need for external review by a clinical events committee may depend on the type of trial conducted.
- Published
- 1998
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31. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team.
- Author
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Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, and Fischl MA
- Subjects
- Acquired Immunodeficiency Syndrome prevention & control, Adult, Anti-HIV Agents adverse effects, CD4 Lymphocyte Count, Disease Progression, Double-Blind Method, Drug Therapy, Combination, Female, HIV Infections immunology, HIV Infections mortality, HIV Protease Inhibitors adverse effects, HIV Protease Inhibitors therapeutic use, Humans, Indinavir adverse effects, Lamivudine adverse effects, Lamivudine therapeutic use, Male, RNA, Viral blood, Reverse Transcriptase Inhibitors therapeutic use, Stavudine adverse effects, Stavudine therapeutic use, Zidovudine adverse effects, Zidovudine therapeutic use, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1, Indinavir therapeutic use
- Abstract
Background: The efficacy and safety of adding a protease inhibitor to two nucleoside analogues to treat human immunodeficiency virus type 1 (HIV-1) infection are not clear. We compared treatment with the protease inhibitor indinavir in addition to zidovudine and lamivudine with treatment with the two nucleosides alone in HIV-infected adults previously treated with zidovudine., Methods: A total of 1156 patients not previously treated with lamivudine or protease inhibitors were stratified according to CD4 cell count (50 or fewer vs. 51 to 200 cells per cubic millimeter) and randomly assigned to one of two daily regimens: 600 mg of zidovudine (or stavudine) and 300 mg of lamivudine, or that regimen with 2400 mg of indinavir. The primary end point was the time to the development of the acquired immunodeficiency syndrome (AIDS) or death., Results: The proportion of patients whose disease progressed to AIDS or death was lower with indinavir, zidovudine, and lamivudine (6 percent) than with zidovudine and lamivudine alone (11 percent; estimated hazard ratio, 0.50; 95 percent confidence interval, 0.33 to 0.76; P=0.001). Mortality in the two groups was 1.4 percent and 3.1 percent, respectively (estimated hazard ratio, 0.43; 95 percent confidence interval, 0.19 to 0.99; P=0.04). The effects of treatment were similar in both CD4 cell strata. The responses of CD4 cells and plasma HIV-1 RNA paralleled the clinical results., Conclusions: Treatment with indinavir, zidovudine, and lamivudine as compared with zidovudine and lamivudine alone significantly slows the progression of HIV-1 disease in patients with 200 CD4 cells or fewer per cubic millimeter and prior exposure to zidovudine.
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- 1997
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32. CD4+ T lymphocyte counts and patterns of mortality among patients infected with human immunodeficiency virus who were enrolled in community programs for clinical research on AIDS.
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Saravolatz L, Neaton JD, Sacks L, Deyton L, Rhame F, and Sherer R
- Subjects
- Adult, Female, Follow-Up Studies, HIV Infections blood, Humans, Male, CD4 Lymphocyte Count, Community Health Services, HIV Infections mortality, HIV Infections physiopathology
- Abstract
CD4+ T lymphocyte measurements are used frequently in clinical practice and have important prognostic implications. In this study, we describe mortality patterns for 5,204 human immunodeficiency virus (HIV)-infected patients classified in different CD4+ cell strata; patients with and patients without a history of disease progression were included. Patients were enrolled in studies sponsored by the Terry Beirn Community Programs for Clinical Research on AIDS of the National Institute of Allergy and Infectious Diseases between September 1990 and December 1993. Over a median follow-up period of 23.6 months, 1,703 of the 5,204 patients died. For those with CD4+ cell counts (/mm3) of < 25, 25-49, 50-99, 100-199, and 200-499, the cumulative mortality rates after 24 months were 72%, 58%, 47%, 27%, and 10%, respectively. The median survival time was 15 months for those with CD4+ cell counts of < 25 cells/mm3; 21 months for those with CD4+ cell counts of 25-49 cells/mm3; and 40 months for patients with CD4+ cell counts of 100-199/mm3. In each CD4+ cell stratum, mortality rates were higher for those with a history of disease progression at entry into the study; across all CD4+ cell strata, mortality was 60% greater (relative risk = 1.6; 95% confidence interval = 1.5-1.8). These data should be useful in planning clinical trials, and they have implications in terms of the frequency with which CD4+ cell counts should be measured to monitor the progression of HIV infection.
- Published
- 1996
- Full Text
- View/download PDF
33. Response of CD4 lymphocytes and clinical consequences of treatment using ddI or ddC in patients with advanced HIV infection.
- Author
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Goldman AI, Carlin BP, Crane LR, Launer C, Korvick JA, Deyton L, and Abrams DI
- Subjects
- Biomarkers, CD4 Lymphocyte Count, Disease Progression, Follow-Up Studies, HIV Infections immunology, HIV Infections mortality, HIV Infections physiopathology, Humans, Regression Analysis, Survival Rate, Treatment Outcome, Antiviral Agents therapeutic use, CD4-Positive T-Lymphocytes immunology, Didanosine therapeutic use, HIV Infections drug therapy, HIV-1, Zalcitabine therapeutic use
- Abstract
The value of CD4 lymphocyte counts as a surrogate marker in persons with advanced human immunodeficiency virus infection during antiretroviral treatment was assessed using longitudinal models and data from the Terry Beirn Community Programs for Clinical Research on AIDS didanosine/zalcitabine trial of 467 HIV-infected patients. Patients with AIDS or two CD4 counts of < or = 300 who fulfilled specific criteria for zidovudine intolerance or failure were randomized to receive either 500 mg didanosine (ddl) daily or 2.25 mg zalcitabine (ddC) per day. Absolute CD4 counts were recorded at study entry and at as many as four visits. Patients were followed for clinical disease progression and survival. At 2 months, the difference in mean CD4 count from baseline was +15.4 cells/mm3 in the ddI group but -1.3 cells/mm3 in the ddC group. Patients assigned to ddI had a greater chance of a CD4 response at 2 months than those on ddC, yet only those in the ddC group with a response showed significant improvement in progression of disease or survival compared with ddC nonresponders, ddI responders, and ddI nonresponders (p = 0.03). We conclude that a CD4 response does not necessarily correlate with improved outcome and is therefore not a useful surrogate marker in these patients.
- Published
- 1996
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34. Considerations in choice of a clinical endpoint for AIDS clinical trials. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA).
- Author
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Neaton JD, Wentworth DN, Rhame F, Hogan C, Abrams DI, and Deyton L
- Subjects
- AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome epidemiology, Disease Progression, Humans, Survival Analysis, Treatment Outcome, Acquired Immunodeficiency Syndrome drug therapy, Clinical Trials as Topic statistics & numerical data, Data Interpretation, Statistical, Models, Statistical
- Abstract
In most clinical trials of antiretroviral therapy for patients infected with HIV, the major outcome variable has been the combined clinical endpoint of any new or recurrent AIDS defining event. We review features of combined endpoints and use data from the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) to evaluate this outcome measure in terms of relevance, diagnostic certainty and sensitivity. We conclude that this endpoint is not relevant because: (i) the 19 different events constituting the combined endpoint are equally weighted in analyses even though they vary considerably in terms of risk of death; and (ii) events after the first are ignored, thus the event profile of patients is not taken into account in making treatment comparisons. We also conclude that power may be low with use of this endpoint if treatments under study do not have an immediate impact on disease progression, if some events which occur soon after randomization represent a disease process that has already begun to incubate, or if treatment differences for the various events constituting the combined endpoint are differentially effected by treatment. Since the ease and certainty of diagnosis of each of the 19 events also vary, we recommend that survival be the primary endpoint of antiretroviral trials, and that all opportunistic events experienced by patients, not just the first, be collected and summarized. Trial reports should include comparisons of incidence of each event by treatment group so that readers can rank events as they please. A single summary measure which considers severity and the entire event profile, as described here, would also be useful for assessing the impact of treatments on quality of life. Further research on approaches for weighting and combining multiple outcome measures is needed.
- Published
- 1994
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- View/download PDF
35. Indeterminate western blot patterns in a cohort of individuals at high risk for human immunodeficiency virus (HIV-1) exposure.
- Author
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Davey RT Jr, Deyton LR, Metcalf JA, Easter M, Kovacs JA, Vasudevachari M, Psallidopoulos M, Thompson LM 3rd, Falloon J, and Polis MA
- Subjects
- Adolescent, Adult, Cohort Studies, HIV Antigens analysis, HIV Infections immunology, HIV Seropositivity diagnosis, HIV Seropositivity immunology, Humans, Male, Middle Aged, Polymerase Chain Reaction, Prospective Studies, Risk Factors, Viral Envelope Proteins analysis, Blotting, Western, HIV Infections diagnosis, HIV-1 immunology
- Abstract
Our objective was to map serial patterns of Western blot reactivity over time of a cohort of initially ELISA-negative, Western blot-indeterminate individuals from a high-risk group and to determine if these individuals were at increased risk of harboring occult HIV-1 infection. A 2-year prospective study used serial ELISA, two types of Western blot, immunologic profiles, HIV-1 culture, and analysis by polymerase chain reaction. Subjects were 20 ELISA-negative, Western blot indeterminate homosexual volunteers and 20 matched seronegative controls. Results showed that 19 of 20 study subjects completed a mean of 17.0 months of clinical and laboratory follow-up. Reactivities with p24 and/or with p55 were the two most commonly observed Western blot patterns, occurring in 70% of individuals. Specific Western blot reactivity was dependent upon the particular immunoblot preparation being used and varied considerably on a longitudinal basis. No individual pattern appeared predictive of an increased likelihood of subsequent seroconversion to HIV-1 relative to controls. By all other criteria including polymerase chain reaction analysis, samples from 17 of 19 individuals remained negative for HIV-1 at each time point. Two individuals evolved from an indeterminate to a positive Western blot and, simultaneously, from a negative to a positive polymerase chain reaction analysis, during follow-up. Our conclusions were as follows. ELISA-negative, Western blot-indeterminate individuals from a high-risk group show marked variability in immunoblot findings over time, and these patterns do not appear predictive of an increased likelihood of infection.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1992
- Full Text
- View/download PDF
36. CD4 counts as predictors of opportunistic pneumonias in human immunodeficiency virus (HIV) infection.
- Author
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Masur H, Ognibene FP, Yarchoan R, Shelhamer JH, Baird BF, Travis W, Suffredini AF, Deyton L, Kovacs JA, and Falloon J
- Subjects
- Cryptococcosis immunology, Cytomegalovirus Infections immunology, HIV Antigens analysis, HIV Core Protein p24, HIV Seropositivity complications, Humans, Leukocyte Count, Lung Neoplasms immunology, Mycobacterium avium-intracellulare Infection immunology, Opportunistic Infections etiology, Pneumonia etiology, Pneumonia, Pneumocystis immunology, Predictive Value of Tests, Retrospective Studies, Retroviridae Proteins analysis, Sarcoma, Kaposi immunology, HIV Seropositivity immunology, Opportunistic Infections immunology, Pneumonia immunology, T-Lymphocytes, Helper-Inducer
- Abstract
Study Objective: To determine if circulating CD4+ lymphocyte counts are predictive of specific infectious or neoplastic processes causing pulmonary dysfunction., Design: Retrospective, consecutive sample study., Setting: Referral-based clinic and wards., Patients: We studied 100 patients infected with human immunodeficiency virus (HIV) who had had 119 episodes of pulmonary dysfunction within 60 days after CD4 lymphocyte determinations., Measurements and Main Results: Circulating CD4 counts were less than 0.200 X 10(9) cells/L (200 cells/mm3) before 46 of 49 episodes of pneumocystis pneumonia, 8 of 8 episodes of cytomegalovirus pneumonia, and 7 of 7 episodes and 19 of 21 episodes of infection with Cryptococcus neoformans and Mycobacterium avium-intracellulare, respectively. In contrast, circulating CD4 counts before episodes of nonspecific interstitial pneumonia were quite variable: Of 41 episodes, 11 occurred when CD4 counts were greater than 0.200 X 10(9) cells/L. The percent of circulating lymphocytes that were CD4+ had a predictive value equal to that of CD4 counts. Serum p24 antigen levels had no predictive value., Conclusions: Pneumocystis pneumonia, cytomegalovirus pneumonia, and pulmonary infection caused by C. neoformans or M. avium-intracellulare are unlikely to occur in HIV-infected patients who have had a CD4 count above 0.200 to 0.250 X 10(9) cells/L (200 to 250 cells/mm3) or a CD4 percent above 20% to 25% in the 60 days before pulmonary evaluation. Patients infected with HIV who have a CD4 count below 0.200 X 10(9) cells/L (or less than 20% CD4 cells) are especially likely to benefit from antipneumocystis prophylaxis.
- Published
- 1989
- Full Text
- View/download PDF
37. Anti-retroviral effects of interferon-alpha in AIDS-associated Kaposi's sarcoma.
- Author
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Lane HC, Kovacs JA, Feinberg J, Herpin B, Davey V, Walker R, Deyton L, Metcalf JA, Baseler M, and Salzman N
- Subjects
- Acquired Immunodeficiency Syndrome immunology, Acquired Immunodeficiency Syndrome microbiology, Acquired Immunodeficiency Syndrome therapy, Adolescent, Adult, CD4-Positive T-Lymphocytes immunology, Clinical Trials as Topic, HIV isolation & purification, Humans, Injections, Subcutaneous, Interferon alpha-2, Leukocyte Count, Male, Middle Aged, Prospective Studies, Recombinant Proteins, Sarcoma, Kaposi etiology, Sarcoma, Kaposi immunology, Sarcoma, Kaposi microbiology, Skin Neoplasms etiology, Skin Neoplasms immunology, Skin Neoplasms microbiology, Time Factors, Virus Cultivation methods, Acquired Immunodeficiency Syndrome complications, Interferon Type I administration & dosage, Interferon-alpha administration & dosage, Sarcoma, Kaposi therapy, Skin Neoplasms therapy
- Abstract
21 patients with AIDS and Kaposi's sarcoma were enrolled in an open therapeutic trial to determine the in vivo anti-retroviral activity of recombinant interferon-alpha (IFN-alpha). 8 (38%) showed a complete or partial anti-tumour response. The mean pretreatment CD4 count for the responders was 399 cells/microliter vs 154 cells/microliter for the non-responders. All 5 of the patients with more than 400 CD4 cells/microliter pretreatment showed a significant reduction in tumour, whereas none of the 7 patients with under 150 CD4 cells/microliter had any response. 5 of the 6 complete or partial responders with greater than 50 pg/ml of human immunodeficiency virus (HIV) p24 before IFN therapy showed a 75% or greater reduction by 12 weeks of therapy, with 3 patients having persistently negative HIV cultures. The anti-viral effects were also most pronounced in the patients with the highest CD4 counts. These data demonstrate the potential benefits, both anti-tumour and anti-retroviral, of treatment with IFN-alpha in the early stages of HIV infection and Kaposi's sarcoma.
- Published
- 1988
- Full Text
- View/download PDF
38. Reversible cardiac dysfunction associated with interferon alfa therapy in AIDS patients with Kaposi's sarcoma.
- Author
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Deyton LR, Walker RE, Kovacs JA, Herpin B, Parker M, Masur H, Fauci AS, and Lane HC
- Subjects
- Acquired Immunodeficiency Syndrome complications, Adult, Heart drug effects, Heart physiopathology, Humans, Male, Acquired Immunodeficiency Syndrome drug therapy, Cardiomyopathy, Dilated etiology, Interferon Type I adverse effects, Sarcoma, Kaposi complications
- Published
- 1989
- Full Text
- View/download PDF
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