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Completed Phase 3 Interventional

A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia

ClinicalTrials.gov ID: NCT00001104

Public ClinicalTrials.gov record NCT00001104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 2:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Placebo Controlled Trial To Evaluate Zidovudine (ZDV) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Hemophilic Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00001104
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
538 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Jan 31, 1990
Last update posted
Oct 31, 2021

Ends 1990

United States locations

U.S. sites
23
U.S. states
12
U.S. cities
19
Facility City State ZIP Site status
Los Angeles County - USC Med Ctr Los Angeles California 90033
Univ of California / San Diego Treatment Ctr San Diego California 921036325
Stanford Univ School of Medicine Stanford California 94305
Northwestern Univ Med School Chicago Illinois 60611
Cook County Hosp Chicago Illinois 60612
Chicago Children's Memorial Hosp Chicago Illinois 606143394
Indiana Univ Hosp Indianapolis Indiana 462025250
Tulane Univ School of Medicine New Orleans Louisiana 70112
Children's Hosp of Boston Boston Massachusetts 021155724
Univ of Massachusetts Med Ctr Worcester Massachusetts 01655
Univ of Minnesota Minneapolis Minnesota 55455
Cornell Univ Med Ctr New York New York 10021
Mount Sinai Med Ctr New York New York 10029
Univ of Rochester Medical Center Rochester New York 14642
Univ of North Carolina Chapel Hill North Carolina 275997215
Holmes Hosp / Univ of Cincinnati Med Ctr Cincinnati Ohio 452670405
Univ Hosp of Cleveland / Case Western Reserve Univ Cleveland Ohio 44106
Ohio State Univ Hosp Clinic Columbus Ohio 432101228
Milton S Hershey Med Ctr Hershey Pennsylvania 170330850
Hemophilia Ctr of Western PA / Univ of Pittsburgh Pittsburgh Pennsylvania 15219
Univ of Pittsburgh Med School Pittsburgh Pennsylvania
Baylor College of Medicine Houston Texas 77030
Univ of Washington Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00001104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 31, 2021 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00001104 live on ClinicalTrials.gov.

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