A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
Status:
Completed
Trial end date:
1990-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)