Back to resultsA 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring United States, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, Zidovudine
Eligibility 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).
Sites / Locations
- Los Angeles County - USC Med Ctr
- UCLA CARE Ctr
- Univ of California / San Diego Treatment Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Stanford Univ School of Medicine
- Univ of Miami School of Medicine
- Charity Hosp / Tulane Univ Med School
- Louisiana State Univ Med Ctr / Tulane Med School
- Tulane Univ School of Medicine
- Johns Hopkins Hosp
- Harvard (Massachusetts Gen Hosp)
- Beth Israel Deaconess - West Campus
- Beth Israel Deaconess Med Ctr
- Univ of Minnesota
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- Beth Israel Med Ctr / Peter Krueger Clinic
- Mem Sloan - Kettering Cancer Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- SUNY / State Univ of New York
- Duke Univ Med Ctr
- Univ of Pittsburgh Med School
- Univ of Washington
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000700
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000700
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1990 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
United States, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, Zidovudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
482 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fischl M
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Stanford at Kaiser / Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Univ School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State Univ Med Ctr / Tulane Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Harvard (Massachusetts Gen Hosp)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jack Weiler Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Montefiore Med Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Bronx Veterans Administration / Mount Sinai Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Beth Israel Med Ctr / Peter Krueger Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY / State Univ of New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Univ of Pittsburgh Med School
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
background
PubMed Identifier
8095980
Citation
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.
Results Reference
background
PubMed Identifier
1863401
Citation
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.
Results Reference
background
PubMed Identifier
2114476
Citation
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.
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
1680135
Citation
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.
Results Reference
background
PubMed Identifier
1977079
Citation
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.
Results Reference
background
PubMed Identifier
2350441
Citation
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.
Results Reference
background
PubMed Identifier
2511447
Citation
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.
Results Reference
background
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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
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