A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Required:

- PCP prophylaxis.

Allowed:

- Topical or oral antifungal agents (other than oral ketoconazole).

- Approved agents for opportunistic infections.

- Antibiotics unless specifically excluded.

- Systemic corticosteroids for no more than 21 days.

- Vitamins.

- Recombinant erythropoietin.

- G-CSF.

- Regularly prescribed medications such as allergy medications, antidepressants,
antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.

Concurrent Treatment:

Allowed:

- Acupuncture.

- Visualization techniques.

Patients must have:

- HIV infection.

- CD4 count <= 200 cells/mm3.

- At least 6 months total prior AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma.

Concurrent Medication:

Excluded:

- Antiretrovirals other than study drugs.

- Rifabutin and rifampin.

- Investigational drugs other than indinavir sulfate.

- Systemic cytotoxic chemotherapy.

- Oral ketoconazole.

- Chronic systemic corticosteroids.

- Herbal therapies.

Patients with the following prior conditions are excluded:

- Unexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry.

- Chronic diarrhea persisting for 15 days within 30 days prior to study entry.

- History of acute or chronic pancreatitis.

- Acute hepatitis within 30 days prior to study entry.

- Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.

- Dose-limiting intolerance to prior AZT at 600 mg/day.

Prior Medication:

Excluded:

- More than 1 week of prior 3TC.

- Any prior protease inhibitors.

- Rifampin or rifabutin within 14 days prior to study entry.

Excluded within 30 days prior to study entry:

- Erythropoietin.

- G-CSF or GM-CSF.

- Non-nucleoside reverse transcriptase inhibitors.

- Interferons.

- Interleukins.

- HIV vaccines.

- Any experimental therapy.