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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infections, Hemophilia A

Intervention / Treatment
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* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Zidovudine
* Drug: Zalcitabine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Zidovudine|nan|
|Drug: Zalcitabine|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indinavir, Drug Therapy, Combination, HIV Protease Inhibitors, Factor VIII, Factor IX, Half-Life, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Platelet Aggregation, Hemophilia A, Hemophilia B