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
Data Collection
Blood-Borne Infections+24
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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. Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.482 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 28 locations
Los Angeles County - USC Med Ctr
Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google MapsUCLA CARE Ctr
Los Angeles, United StatesUniv of California / San Diego Treatment Ctr
San Diego, United StatesSan Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, United States