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NCT00001104 · ClinicalTrials.gov registry record · Phase 3
A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 538
- Enrollment target
- 20
- Study locations
NCT00001104: Completed Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001104 is a Phase 3 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 538 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001104, a Phase 3 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 538 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Zidovudine
Study Locations (20)
California
- Los Angeles County - USC Med Ctr - Los Angeles
- Univ of California / San Diego Treatment Ctr - San Diego
- Stanford Univ School of Medicine - Stanford
Illinois
- Northwestern Univ Med School - Chicago
- Cook County Hosp - Chicago
- Chicago Children's Memorial Hosp - Chicago
New York
- Cornell Univ Med Ctr - New York
- Mount Sinai Med Ctr - New York
- Univ of Rochester Medical Center - Rochester
Ohio
- Holmes Hosp / Univ of Cincinnati Med Ctr - Cincinnati
- Univ Hosp of Cleveland / Case Western Reserve Univ - Cleveland
- Ohio State Univ Hosp Clinic - Columbus
Massachusetts
- Children's Hosp of Boston - Boston
- Univ of Massachusetts Med Ctr - Worcester
Pennsylvania
- Milton S Hershey Med Ctr - Hershey
- Hemophilia Ctr of Western PA / Univ of Pittsburgh - Pittsburgh
Indiana
- Indiana Univ Hosp - Indianapolis
Louisiana
- Tulane Univ School of Medicine - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 538 participants |
| Est. Completion | 1990-02 |
| Phase | Phase 3 |
What the finished NCT00001104 record still lists
NCT00001104 is an interventional study that assigns participants to a tested intervention. The registered 538 participants enrollment target is mid-sized for trials with a published cap, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (21% higher).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Zidovudine is the first listed.
NCT00001104 names 20 study sites across 10 states, led by California, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT00001104 about?
NCT00001104 is a clinical study titled "A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia". 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-...
What is the current status of trial NCT00001104?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 538 participants. Estimated completion is 1990-02.
What conditions does trial NCT00001104 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001104?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00001104?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001104 being conducted?
This trial has 20 study locations across California, Illinois, Indiana, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001104's enrollment target sits among peer trials
538 57th of 542 higher than 486 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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