search
Back to results

A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections. Concurrent Treatment: Allowed: Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults). Patients must have: HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms. Exclusion Criteria Co-existing Condition: Patients with the following conditions will be excluded: Symptomatic, visceral Kaposi's sarcoma. Lymphedema. HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire. Concurrent Medication: Excluded: Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator. Cimetidine. Flurazepam. Indomethacin. Ranitidine. Probenecid. Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity. Prophylaxis or chronic suppression of herpes simplex. Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days. Concurrent Treatment: Excluded: Radiation therapy for treatment of Kaposi's sarcoma lesions. The following patients will be excluded from the study: Patients with a history of any AIDS-defining opportunistic infection. Patients with any of the following constitutional symptoms with no etiology established: Temperature more than 38 degrees and/or drenching night sweats for more than 1 month; watery diarrhea for 2 or more weeks; weight loss of more than 10 percent. Patients with a history of other systemic malignancies or lymphomas. Prior Medication: Excluded: Systemic antineoplastic chemotherapy. Zidovudine (AZT). Excluded within 30 days of study entry: Antiretroviral agents. Immunomodulating agents. Prophylaxis for Pneumocystis carinii pneumonia. Prophylaxis for herpes simplex virus infections. Any other experimental therapy. Prior Treatment: Excluded within 30 days of study entry: Any experimental therapy. Active substance abuse.

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
  • 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)
  • Univ of Minnesota
  • Bronx Veterans Administration / Mount Sinai Hosp
  • SUNY / Erie County Med Ctr at Buffalo
  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
  • Beth Israel Med Ctr / Peter Krueger Clinic
  • Bellevue Hosp / New York Univ Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Mount Sinai Med Ctr
  • Univ of Rochester Medical Center
  • SUNY / State Univ of New York
  • Duke Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000994
Brief Title
A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
Official Title
A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma
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 determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan. Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Detailed Description
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions. Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections. Concurrent Treatment: Allowed: Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults). Patients must have: HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms. Exclusion Criteria Co-existing Condition: Patients with the following conditions will be excluded: Symptomatic, visceral Kaposi's sarcoma. Lymphedema. HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire. Concurrent Medication: Excluded: Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator. Cimetidine. Flurazepam. Indomethacin. Ranitidine. Probenecid. Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity. Prophylaxis or chronic suppression of herpes simplex. Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days. Concurrent Treatment: Excluded: Radiation therapy for treatment of Kaposi's sarcoma lesions. The following patients will be excluded from the study: Patients with a history of any AIDS-defining opportunistic infection. Patients with any of the following constitutional symptoms with no etiology established: Temperature more than 38 degrees and/or drenching night sweats for more than 1 month; watery diarrhea for 2 or more weeks; weight loss of more than 10 percent. Patients with a history of other systemic malignancies or lymphomas. Prior Medication: Excluded: Systemic antineoplastic chemotherapy. Zidovudine (AZT). Excluded within 30 days of study entry: Antiretroviral agents. Immunomodulating agents. Prophylaxis for Pneumocystis carinii pneumonia. Prophylaxis for herpes simplex virus infections. Any other experimental therapy. Prior Treatment: Excluded within 30 days of study entry: Any experimental therapy. Active substance abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentine FT
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
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
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
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
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
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
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
1903261
Citation
Chaisson RE, Fuchs E, Stanton DL, Quinn TC, Hendricksen C, Bartlett JG, Farzadegan H. Racial heterogeneity of HIV antigenemia in people with HIV infection. AIDS. 1991 Feb;5(2):177-80. doi: 10.1097/00002030-199102000-00007.
Results Reference
background

Learn more about this trial

A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

We'll reach out to this number within 24 hrs