A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
A Placebo Controlled Trial To Evaluate Zidovudine (ZDV) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Hemophilic Patients
2 other identifiers
interventional
538
1 country
23
Brief Summary
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of ZDV in hemophilic patients will also be studied. Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to his wife or other female sexual partner. To determine the effectiveness of counseling and education on the behaviors of the wives that place them at risk for HIV infection. To determine if antibodies to HIV either appear or disappear from the blood of any of the wives during the study. Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV. Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1990
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed with caution for Study A:
- Hepatotoxic drugs.
- Patients in Study A must have:
- Hemophilia with no symptoms for AIDS. Most patients will have well-established factor 8 or 9 deficiency. However, patients with other coagulation diseases, such as factor 5 deficiency, and von Willebrand disease, will also be acceptable for the study.
- Wives in Study B are included even if they are known to be seropositive or are not sexually active at the time the study starts.
- Prior Medication:
- Allowed for Study A:
- Patients who were on the Phase I ZDV study, ACTG 017, or are on ACTG 062 may enter after waiting 3 weeks.
You may not qualify if:
- Co-existing Condition:
- Patients in Study A with the following symptoms or conditions are excluded:
- AIDS-defining illness.
- Severe ARC.
- Severe or prolonged toxicity.
- Concurrent Medication:
- Excluded for Study A:
- Isoniazid or rifampin.
- Treatment for Pneumocystis carinii pneumonia (PCP), oral candidiasis, and localized cutaneous herpes simplex or zoster infections.
- Probenecid.
- Aspirin on a regular basis, or for more than 72 hours without contacting the investigator.
- Drugs causing neutropenia or significant risk of nephrotoxicity.
- Patients in Study A with the following prior conditions are excluded:
- AIDS-defining opportunistic infection or malignancy.
- Unexplained temperature greater than 38 C for more than 5 consecutive days or more than 10 days in any 30-day period in the 2 years prior to entry.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Stanford Univ School of Medicine
Stanford, California, 94305, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Univ of Washington
Seattle, Washington, 98105, United States
Related Publications (1)
Price W, Merigan T, Peterman T. Condom usage reported by female sexual partners of asymptomatic HIV seropositive hemophilic men. Int Conf AIDS. 1989 Jun 4-9;5:420 (abstract no ThBP30)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thomas C. Merigan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1990
Last Updated
November 1, 2021
Record last verified: 2021-10