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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.

Key facts

Study ID

NCT00000700

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

482

Expected to finish

1990-05-01

Last updated by the study team

2021-11-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• Stanford Univ School of Medicine — Stanford, California, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Louisiana State Univ Med Ctr / Tulane Med School — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst, New York, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• SUNY / State Univ of New York — Syracuse, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
• Jack Weiler Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
• Bronx Veterans Administration / Mount Sinai Hosp — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.