The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs

Inclusion Criteria

Concurrent Medication:

Required:

• TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.

Allowed:

• Atovaquone.
• IV pentamidine.
• TMP / SMX.
• Trimetrexate.
• Trimethoprim-dapsone.
• Clindamycin-primaquine.
• Topical antifungals.
• Clotrimazole.
• Ketoconazole.
• Fluconazole.
• Amphotericin B.
• Itraconazole.
• Rifabutin.
• Isoniazid.
• Pyrazinamide.
• Clofazimine.
• Clarithromycin.
• Azithromycin.
• Ethambutol.
• Amikacin.
• Ciprofloxacin.
• Ofloxacin.
• Pyrimethamine.
• Sulfadiazine.
• Clindamycin.
• Filgrastim ( G-CSF ).
• Up to 1000 mg/day acyclovir.
• Erythropoietin.
• Antibiotics.
• Antipyretics.
• Analgesics.
• Antiemetics.
• Rifampin.

Concurrent Treatment:

Allowed:

• Local radiation therapy.

Patients must have:

• HIV infection.
• CD4 count 300 - 600 cells/mm3.
• NO history of AIDS.
• NO active opportunistic infection.
• NO prior nucleoside therapy.
• Life expectancy at least 2 years.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.
• Malignancy requiring systemic cytotoxic chemotherapy.
• Active grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

• Antiretrovirals other than study drugs.
• Systemic cytotoxic chemotherapy.
• Foscarnet.

Patients with the following prior conditions are excluded:

• Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days prior to study entry.
• Unexplained temperature >= 38.5 C for any 7 days within 30 days prior to study entry.
• Active participation in other experimental therapy within 30 days prior to study entry.

Prior Medication:

Excluded:

• Prior nucleoside antiretrovirals of 1 week or longer duration.
• Any antiretroviral within 90 days prior to study entry.
• Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry.
• Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.