A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

Inclusion Criteria

Concurrent Medication:

Required:

• PCP prophylaxis.

Allowed:

• Erythropoietin maintenance.
• G-CSF and GM-CSF.
• Prophylaxis for Mycobacterium avium intracellulare.
• Antifungal prophylaxis or treatment with specific drugs.
• Maintenance therapy for opportunistic infection.
• Over-the-counter medications or alternative therapies such as vitamins and herbs.
• Antibiotics as clinically indicated.
• Steroids for < 21 days for acute problems.
• Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications.

Concurrent Treatment:

Allowed:

• Radiation therapy for cutaneous Kaposi's sarcoma.
• Acupuncture.

Patients must have:

• Documented HIV infection.
• CD4 count <= 50 cells/mm3.
• Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance.
• Life expectancy of at least 6 months.
• Consent of parent or guardian if < 18 years of age.
• Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment).

NOTE:

• Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Abnormal baseline chest x-ray.
• New pulmonary or cardiac symptoms.
• Psychological or emotional problems sufficient to prevent compliance with study medication.

Concurrent Medication:

Excluded:

• Systemic chemotherapy for malignancy.
• Acute or induction therapy for opportunistic infection.
• Antiretroviral drugs other than study drugs.
• Biological response modifiers.
• Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin.

Patients with the following prior conditions are excluded:

• History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.
• Evidence of active pulmonary disease within 6 months prior to study entry.
• History of grade 3 or worse peripheral neuropathy.
• History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

• Prior nevirapine.

Excluded within 7 days prior to study entry:

• Acute therapy for opportunistic infection (maintenance therapy is permitted).
• Acute systemic therapy for a nonopportunistic infection or other medical condition.
• Antiretroviral drugs other than AZT, ddI, or ddC.
• Biological response modifiers.
• d4T therapy.
• Nucleosides other than those used in the study.
• Antibiotics containing clavulanate potassium.

Prior Treatment:

Excluded:

• More than 4 units of blood in a 30-day period.

Active alcohol or drug abuse.