Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

Inclusion Criteria

Concurrent Medication:

Allowed:

• Chemoprophylaxis for Pneumocystis carinii pneumonia.
• Antibiotics, antifungals, and antiviral medications, as clinically indicated.
• Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider.

Concurrent Treatment:

Allowed:

• Limited localized radiation therapy to the skin.

Prior Medication: Required:

• AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry.

Patients must have:

• Asymptomatic HIV infection.
• CD4 count 300-600 cells/mm3.
• No plasma/serum PCR for codon 215 mutation at screening.
• Prior AZT monotherapy.

NOTE:

• All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged.

AS PER AMENDMENT 04/03/95:

• DOD female patients must have a negative pregnancy test within 48 hours prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Symptomatic grade 2 or worse peripheral neuropathy.
• Unable to swallow capsules and tablets.
• Other medical condition that contraindicates study participation.

Concurrent Medication:

Excluded:

• Systemic cytotoxic chemotherapy.
• Biologic response modifiers (such as interferon, ampligen, or PEG-IL2).
• Anti-HIV agents other than study drugs.
• Other investigational agents.
• Foscarnet unless clinically indicated for unresponsive herpes virus infection.
• Chronic antacid or H-2 blocker use.
• Rifampin or rifamycin class agents.
• Antibiotics containing clavulanic acid.

Concurrent Treatment:

Excluded:

• Radiation therapy other than limited localized therapy to skin.

Patients with the following prior condition are excluded:

• History of pancreatitis.

Prior Medication:

Excluded:

• Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT.
• Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening.

Prior Treatment:

Excluded:

• Blood transfusion within the preceding 2 weeks.

Illicit drug or alcohol abuse.