A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

Inclusion Criteria

Concurrent Medication:

Allowed:

• All concomitant medication to minimum and record.

• Any approved medications can be used to treat an opportunistic infection.

• Dapsone may be used for Pneumocystis carinii pneumonia (PCP).

• Pyrimethamine - sulfadoxine may be used for toxoplasmosis.

• Ganciclovir for cytomegalovirus may be used for maintenance only.

• Prophylactic therapy for PCP.

Concurrent Treatment:

Allowed:

• Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is used.

Patients must have:

• HIV seropositivity as confirmed by any federally licensed ELISA test kit.

• Allowed:

• Malignancy in past which has been in complete remission for 1 year without therapy.

Exclusion Criteria

Co-existing Condition:

Patients with active opportunistic infections will be excluded.

Concurrent Medication:

Excluded:

• Aspirin on a regular basis or beyond 72 hours without contacting investigator.

• Cimetidine.

• Flurazepam.

• Indomethacin.

• Ranitidine.

• Probenecid.

Patients with the following are excluded:

• Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry.

• Other concurrent neoplasms other than basal cell carcinoma of the skin.

• Requiring blood transfusions > once per month. Last transfusion cannot have been given within 7 days of entry.

• Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary.

Prior Medication:

Excluded within 2 weeks of study entry:

• Treatment for acute Pneumocystis carinii pneumonia (PCP).

• Excluded within 30 days of study entry:

• Other antiretroviral agents, immunomodulating agents, or corticosteroids.

Prior Treatment:

Excluded within 30 days of study entry:

• Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma.

Required:

• Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii pneumonia (PCP).