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

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).