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Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002386
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia
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
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.
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.
Interventional
Phase 4
Primary Purpose: Treatment
  • HIV Infections
  • Hemophilia A
  • Drug: Indinavir sulfate
  • Drug: Lamivudine
  • Drug: Stavudine
  • Drug: Zidovudine
  • Drug: Zalcitabine
  • Drug: Didanosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
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Inclusion Criteria

You may be eligible for this study if you:

  • Are an HIV-positive male.
  • Have been diagnosed with hemophilia.
  • Have been taking clotting factors for hemophilia for at least 6 months.
  • Have been taking a combination of one protease inhibitor plus two other anti-HIV drugs for at least 6 months, or have never taken a protease inhibitor.
  • Are at least 16 years old (consent of parent or guardian required if under 18).
Sexes Eligible for Study: Male
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00002386
246J
065-00
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP