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

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.