Inclusion Criteria
Concurrent Medication:
Allowed:
- AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).
- Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to < 200 cells/mm3.
- Other marketed drugs as required.
Patients must have:
- HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
- No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.
- Mean CD4 of 200-500 cells/mm3.
- HIV-1 positive PCR RNA.
- Ability to self-administer study drug by IM injection.
- Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at >= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Malignancy.
- Hematuria.
- Proteinuria > 1+.
Concurrent Medication:
Excluded:
- Non-antiretroviral agents with known or suspected activity against HIV.
- Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.
Patients with the following prior conditions are excluded:
Myositis within the past 6 months.
Prior Medication:
Excluded:
- Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.
- Prior antiretroviral therapy (AZT-naive patients only).
Prior Treatment:
Excluded within 6 weeks prior to study entry:
- Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
Purpose
