A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy

Inclusion Criteria

Concurrent Medication:

Required:

• PCP prophylaxis.

Allowed:

• Erythropoietin.
• Prophylaxis for MAI or fungal infections.
• Antibiotics.
• Over-the-counter, alternative, or regularly prescribed drugs.
• Steroids, if for < 21 days.

Concurrent Treatment:

Allowed:

• Radiation therapy for cutaneous Kaposi's sarcoma.

Patients must have:

• HIV infection.
• CD4 count <= 50 cells/mm3.
• Prior nucleoside monotherapy for at least 6 months.
• Life expectancy of at least 6 months.

Prior Medication: Required:

• Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Severe peripheral neuropathy.
• Psychological or emotional problems sufficient to prevent study compliance.

Concurrent Medication:

Excluded:

• Systemic chemotherapy for malignancy.
• Acute or induction therapy for opportunistic infection.

Patients with the following prior conditions are excluded:

• History of acute or chronic pancreatitis.
• Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.

Prior Medication:

Excluded:

• Non-study nucleosides or biologic response modifiers within 7 days prior to study entry.
• Acute therapy for opportunistic process within 14 days prior to study entry.
• Acute systemic therapy for other medical conditions within 14 days prior to study entry.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety