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
NCT ID: NCT00000700
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
482 participants
INTERVENTIONAL
1990-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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).
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Fischl M
Role: STUDY_CHAIR
Locations
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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
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Fischl M, Parker CB, Pettinelli C, Wulfsohn M, Rasheed S. The efficacy and safety of a lower dose of zidovudine in the treatment of patients with AIDS-associated PCP. Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no ThB20)
De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1993 Apr;6(4):359-65.
McMahon DK, Winkelstein A, Armstrong JA, Pazin GJ, Hawk H, Ho M. Zidovudine therapy is associated with an increased capacity of phytohemagglutinin-stimulated cells to express interleukin-2 receptors. Pittsburgh AIDS Clinical Trial Unit. AIDS. 1991 May;5(5):491-6. doi: 10.1097/00002030-199105000-00003.
Richman DD, Grimes JM, Lagakos SW. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. J Acquir Immune Defic Syndr (1988). 1990;3(8):743-6.
Wulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419)
Rinaldo C, Huang XL, Piazza P, Armstrong J, Rappocciolo G, Pazin G, McMahon D, Gupta P, Fan Z, Zhang Z, et al. Augmentation of cellular immune function during the early phase of zidovudine treatment of AIDS patients. J Infect Dis. 1991 Oct;164(4):638-45. doi: 10.1093/infdis/164.4.638.
Fischl MA, Parker CB, Pettinelli C, Wulfsohn M, Hirsch MS, Collier AC, Antoniskis D, Ho M, Richman DD, Fuchs E, et al. A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1990 Oct 11;323(15):1009-14. doi: 10.1056/NEJM199010113231501.
Unadkat JD, Collier AC, Crosby SS, Cummings D, Opheim KE, Corey L. Pharmacokinetics of oral zidovudine (azidothymidine) in patients with AIDS when administered with and without a high-fat meal. AIDS. 1990 Mar;4(3):229-32. doi: 10.1097/00002030-199003000-00008.
Coombs RW, Collier AC, Allain JP, Nikora B, Leuther M, Gjerset GF, Corey L. Plasma viremia in human immunodeficiency virus infection. N Engl J Med. 1989 Dec 14;321(24):1626-31. doi: 10.1056/NEJM198912143212402.
Other Identifiers
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10978
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 002
Identifier Type: -
Identifier Source: org_study_id