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Sponsored by: |
Merck |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002386 |
The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood clotting in HIV-positive patients with hemophilia.
Condition | Intervention | Phase |
HIV Infections Hemophilia A |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase IV |
Genetics Home Reference related topics: | hemophilia |
MedlinePlus related topics: | AIDS AIDS Medicines Hemophilia |
ChemIDplus related topics: | Zidovudine Lamivudine Indinavir Indinavir Sulfate Didanosine Stavudine Zalcitabine Factor IX Factor VIII Octocog alfa |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Multiclinic, Open Pilot Study to Investigate the Effect of Combination Antiretroviral Therapy Including Indinavir Sulfate on Coagulation Factors, on Platelet Aggregation, and on Factor VIII/IX Half-Life in HIV-1 Seropositive Patients With Hemophilia A or B |
Estimated Enrollment: | 55 |
Patients are enrolled in one of two study groups. The treatment group consists of HIV-1 seropositive patients with hemophilia A or B who are protease-inhibitor naive. The laboratory control group consists of HIV-1 seropositive patients with hemophilia A who are on a stable, triple-combination antiretroviral regimen. Patients in the treatment group receive indinavir sulfate plus two of the following NRTIs: zidovudine (ZDV), didanosine (ddI), zalcitabine (ddC), stavudine (d4T), or lamivudine (3TC). Patients in the treatment group preferably are naive to one or both of the NRTIs. Patients in the laboratory control group continue on their stable triple antiretroviral regimen consisting of a protease inhibitor plus two NRTIs. Patients in the control group are not provided antiretroviral medications as part of this study. Patients in the treatment group are evaluated by physical examination, safety laboratory tests, CD4 cell counts, and viral load on Day 1 and at Weeks 2, 4, 8, and 12 and then every 8 weeks through Week 52. Patients in the control group are evaluated by physical examination, safety laboratory tests, CD4 cell counts, and viral load on Day -1 and at Week 12. All patients receive their usual factor concentrate infusion over a 10-minute period on Day -1 and at Week 12 to estimate factor VIII (or IX) recovery and half-life. Blood samples are taken prior to infusion and 30 minutes and 1, 3, 6, 9, 12, and 24 hours after infusion. All patients are required to keep a daily log documenting bleeding episodes and use of factor VIII (or IX) throughout the study.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
United States, California | |||||
USCF | |||||
San Francisco, California, United States, 94143 | |||||
United States, District of Columbia | |||||
Georgetown U Med Ctr / Div of Hematology / Oncology | |||||
Washington, District of Columbia, United States, 20007 | |||||
United States, Georgia | |||||
Emory Univ | |||||
Atlanta, Georgia, United States, 30322 | |||||
United States, Indiana | |||||
Riley Hosp for Children | |||||
Indianapolis, Indiana, United States, 462025225 | |||||
United States, Louisiana | |||||
Tulane Univ School of Medicine / Hematology / Oncology | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, North Carolina | |||||
Univ of North Carolina School of Medicine / Div Hemat / Onco | |||||
Chapel Hill, North Carolina, United States, 275997035 | |||||
United States, Pennsylvania | |||||
Milton Hershey Med Ctr | |||||
Hershey, Pennsylvania, United States, 170330850 | |||||
Canada, Quebec | |||||
Montreal Gen Hosp | |||||
Montreal, Quebec, Canada |
Merck |
Study ID Numbers: | 246J, 065-00 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002386 |
Health Authority: | United States: Food and Drug Administration |
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