Safety and efficacy of thymopentin in zidovudine (AZT)-treated asymptomatic HIV-infected subjects with 200-500 CD4 cells/mm3: a double-blind placebo-controlled trial
| Autor: | Gideon Goldstein, Marcus A. Conant, Gildon Beall, Howard A. Grossman, Jeffrey E. Galpin, Gary Blick, Leonard H. Calabrese, Robert L. Hirsch, Alan Fisher, Patti Stampone, Linda A. Meyerson |
|---|---|
| Rok vydání: | 1995 |
| Předmět: |
Adult
Male medicine.medical_specialty Injections Subcutaneous Immunology Placebo-controlled study HIV Core Protein p24 HIV Infections Placebo Asymptomatic Zidovudine Double-Blind Method Virology Internal medicine Immunopathology Trimethoprim Sulfamethoxazole Drug Combination medicine Immunology and Allergy Humans Thymopentin Sida Pentamidine Proportional Hazards Models biology business.industry Pneumonia Pneumocystis HIV Drug Resistance Microbial Middle Aged biology.organism_classification Prognosis CD4 Lymphocyte Count Relative risk Disease Progression Patient Compliance Drug Therapy Combination Female medicine.symptom business medicine.drug Follow-Up Studies |
| Zdroj: | Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association. 8(3) |
| ISSN: | 1077-9450 |
| Popis: | Thymopentin, 50 mg subcutaneously (s.c.) 3 times per week, was evaluated in a double-blind, randomized, placebo-controlled trial of zidovudine (AZT)-treated asymptomatic human immunodeficiency virus (HIV)-infected subjects with 200-500 CD4 cells/mm3 at entry. The 352 subjects were prestratified by prior AZT use into stratum I (235 subjects, > 6 months AZT at entry) and stratum II (117 subjects, < or = 6 months AZT at entry). Clinical end points, CD4 cell counts, serum p24, serum immune complex dissociated (ICD) p24, and safety variables were evaluated through 48 weeks, using an intent-to-treat analysis. The two strata were analyzed individually because they yielded different clinical outcomes, with a statistically significant treatment-by-stratum interaction. In stratum I (mean, 16 months AZT at entry) two AIDS or death events occurred in thymopentin and 10 in placebo recipients (p = 0.024; relative risk (RR) estimate, 4.9 [95% confidence limit (CI), 1.1 to 22.2]). There were three AIDS-related complex (ARC), AIDS, or death events in thymopentin and 18 in placebo recipients [p = 0.001; RR estimate, 5.9 (95% CI, 1.7 to 20.0)]. In stratum II (mean, 3 months AZT at entry), four AIDS or death events occurred in thymopentin and none in placebo recipients (p = 0.11), and four ARC, AIDS, or death events occurred in thymopentin and two in placebo recipients (p = 0.79). The treatment groups did not differ significantly with respect to changes in CD4 counts or p24 antigen levels or with respect to clinical adverse experiences or laboratory abnormalities. Thus, AZT-experienced placebo-treated subjects had relatively high progression rates to AIDS or death and to ARC, AIDS, or death, and these rates were reduced by thymopentin treatment. In contrast, placebo-treated subjects with little prior AZT experience had low progression rates; these were not significantly changed by thymopentin treatment. There was no increase in the incidence of adverse reactions with thymopentin. |
| Databáze: | OpenAIRE |
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