A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or
localized or disseminated zoster infections.

Concurrent Treatment:

Allowed:

- Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's
cardiovascular status is compromised or if the hemoglobin fails to show signs of
recovery following withdrawal from the study drug. Toxicity grades according to NIAID
Recommendations for Grading Acute and Subacute Toxic Effects (Adults).

Patients must have:

- HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without
constitutional symptoms.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

- Symptomatic, visceral Kaposi's sarcoma.

- Lymphedema.

- HIV neurologic disease as determined by a standard neurologic examination and
neuropsychological questionnaire.

Concurrent Medication:

Excluded:

- Aspirin or acetaminophen on a regular basis or for longer than 72 hours without
approval of investigator.

- Cimetidine.

- Flurazepam.

- Indomethacin.

- Ranitidine.

- Probenecid.

- Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity.

- Prophylaxis or chronic suppression of herpes simplex.

- Treatment of herpes simplex virus cutaneous disease more often than once a month for
5 - 7 days.

Concurrent Treatment:

Excluded:

- Radiation therapy for treatment of Kaposi's sarcoma lesions.

The following patients will be excluded from the study:

- Patients with a history of any AIDS-defining opportunistic infection.

- Patients with any of the following constitutional symptoms with no etiology
established:

- Temperature more than 38 degrees and/or drenching night sweats for more than 1 month;
watery diarrhea for 2 or more weeks; weight loss of more than 10 percent.

- Patients with a history of other systemic malignancies or lymphomas.

Prior Medication:

Excluded:

- Systemic antineoplastic chemotherapy.

- Zidovudine (AZT).

- Excluded within 30 days of study entry:

- Antiretroviral agents.

- Immunomodulating agents.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Prophylaxis for herpes simplex virus infections.

- Any other experimental therapy.

Prior Treatment:

Excluded within 30 days of study entry:

- Any experimental therapy.

- Active substance abuse.