Zidovudine therapy of asymptomatic HIV infected persons with less than 500 CD4+ cells/mm3

Zidovudine therapy of asymptomatic HIV infected persons with less than 500 CD4+ cells/mm3 - ACTG protocol 019.

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Zidovudine therapy of asymptomatic HIV infected persons with less than 500 CD4+ cells/mm3 - ACTG protocol 019.

Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no. Th.B.17). Unique Identifier : AIDSLINE ICA6/10001790
Volberding P; Lagakos S; Koch M; Pettinelli C; Myers M; Booth D; University of California, San Francisco, California, USA

Abstract: OBJECTIVES: Determine the safety and efficacy of zidovudine (ZDV) in asymptomatic HIV-infected subjects with CD4+ cell counts below 500/mm3. METHODS: Randomized trial of 1338 HIV-infected asymptomatic subjects with fewer than 500 CD4+ cells/mm3 comparing two dosages of ZDV (500 mg daily, 1500 mg daily in 5 doses) to placebo. Efficacy determined by a delay in progression to advanced ARC or AIDS or improvements in immunologic or virologic parameters. RESULTS: Entry clinical and laboratory parameters were comparable in all treatment groups. Mean treatment duration was 55 weeks. 33 of 428 subjects in the placebo group developed AIDS compared with 11 of 453 in the 500 mg daily ZDV dosage group (p=.001) and 14 of 457 in the 1500 mg group (p=.02). Progression to either AIDS or advanced ARC occurred in 38 placebo subjects, 17 (p=.006) in the 500 mg ZDV group and 19 (p=.05) in the 1500 mg ZDV group. Significant benefit was also shown in CD4+ cell counts and HIV p24 antigen levels. The 1500 mg ZDV group had a significantly higher rate of severe hematologic toxicity (p less than .0001). Severe anemia and neutropenia noted in 6.3% and 6.3% in the 1500 mg ZDV group; in 1.1% and 1.8% in the 500 mg group and in 0.2% and 1.6% in the placebo group. Nausea was the only severe toxicity seen significantly more often in the 500 mg (5%) group than in the placebo group (1%). Study compliance was very good, and loss to follow-up rates were less than 10% in each group. CONCLUSIONS: ZDV in a total daily dosage of 500 mg is safe and can decrease the 1 year progression rate to AIDS in asymptomatic HIV-infected subjects with less than 500 CD4+ cells/mm3.

Keywords: Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL AIDS-Related Complex/PREVENTION & CONTROL *CD4-Positive T-Lymphocytes Human HIV Infections/*DRUG THERAPY Leukocyte Count Randomized Controlled Trials Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL
901230
M90C3701

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