A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome

Article Abstract:

Zidovudine, formerly called AZT, has been found to slow the clinical progression of AIDS and inhibit the cellular replication of HIV (human immunodeficiency virus, which causes AIDS). Unfortunately, the benefits of zidovudine treatment are not without significant risk of side effects, such as anemia (diminished population of red blood cells), and neutropenia (fewer white blood cells). These side effects can severely compromise the health status of patients with AIDS. The present standard dose of zidovudine is 1,500 milligrams (mg) per day. This clinical trial documents the effects of reduced dose levels of zidovudine in patients with AIDS. Individuals who had experienced their first bout of Pneumocystis carinii pneumonia at least two weeks earlier were eligible for entrance into the study. However, patients who had previously been treated with zidovudine or had experienced multiple episodes of Pneumocystis carinii pneumonia, or Kaposi's sarcoma (a lung tumor that affects AIDS patients) were ineligible. The participants (524) were equally divided into two groups: the standard-treatment group received 250 mg of zidovudine every 4 hours; and the reduced-treatment group was given 200 mg of zidovudine every 4 hours for four weeks, when the dose was reduced to 100 mg of zidovudine every 4 hours. The patients were followed for a period of up to 25.6 months. Blood specimens were examined for the presence of HIV antigen (a protein associated with HIV infection), and the number of CD4-T lymphocytes (a specific class of white blood cells that decreases in number as AIDS worsens). The survival rates at 18 months were 52 percent for the standard-treatment group and 63 percent for the reduced-treatment group. The percentage of patients who developed opportunistic infections was the same in both groups (82 percent). Zidovudine transiently improved the CD4-T lymphocyte count in both treatment groups. Patients treated with the reduced dose strategy experienced significantly less anemia and neutropenia. The findings demonstrate that reducing the daily dose of zidovudine provides effective treatment for AIDS patients, and is associated with a reduction of some side effects. (Consumer Summary produced by Reliance Medical Information, Inc.)

Patient outcomes, Mortality, Anemia, Measurement, Causes of, Complications and side effects, T cells, AIDS (Disease), Neutropenia

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A comparison of immediate with deferred zidovudine therapy for asymptomatic HIV-infected adults with CD4 cell counts of 500 or more per cubic millimeter

Article Abstract:

Zidovudine treatment of HIV-infected adults in the early stages of infection may not extend survival with or without AIDS. HIV-infected individuals without symptoms and with a CD4 cell count of at least 500 cells/cubic milliliter were divided into three groups: 547 who initially received a placebo, 549 who received 500 milligrams/day of zidovudine, and 541 who received 1500 mg/day of zidovudine. After two years all participants were given the option of receiving 500 mg/day of zidovudine. Patients were followed for a median of 5 years. There were no significant differences between the groups in survival without AIDS. The death rate in each group was approximately 2 years/100 person-years of follow-up. However, the median amount of time for CD4 counts to drop below 500 cells/cubic ml was 1.0 in the delayed treatment group and 1.5 in the immediate treatment groups. Thus, early treatment did delay CD4 depletion. The overall frequency of side effects was low, but most significant in the 1500 mg/day group.

HIV infection, HIV infections

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