- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000700
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
Study Overview
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Ctr
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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San Diego, California, United States, 921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco, California, United States, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
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San Francisco, California, United States, 94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Stanford, California, United States, 94305
- Stanford Univ School of Medicine
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Florida
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Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana State Univ Med Ctr / Tulane Med School
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New Orleans, Louisiana, United States, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, United States, 70112
- Charity Hosp / Tulane Univ Med School
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Med Ctr
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Univ of Minnesota
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New York
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Bronx, New York, United States, 10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Bronx, New York, United States, 10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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Bronx, New York, United States, 10467
- Montefiore Med Ctr / Bronx Municipal Hosp
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Bronx, New York, United States, 10468
- Bronx Veterans Administration / Mount Sinai Hosp
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Elmhurst, New York, United States, 11373
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
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New York, New York, United States, 10003
- Beth Israel Med Ctr / Peter Krueger Clinic
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New York, New York, United States, 10021
- Mem Sloan - Kettering Cancer Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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Syracuse, New York, United States, 13210
- SUNY / State Univ of New York
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Univ of Pittsburgh Med School
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Washington
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Seattle, Washington, United States, 98105
- Univ of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Investigators
- Study Chair: Fischl M
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- ACTG 002
- 10978 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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