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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Hemophilia A

Intervention: Indinavir sulfate (Drug); Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug); Zalcitabine (Drug); Didanosine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

Detailed description: 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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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).

Locations and Contacts

USCF, San Francisco, California 94143, United States

Georgetown U Med Ctr / Div of Hematology / Oncology, Washington, District of Columbia 20007, United States

Emory Univ, Atlanta, Georgia 30322, United States

Riley Hosp for Children, Indianapolis, Indiana 462025225, United States

Tulane Univ School of Medicine / Hematology / Oncology, New Orleans, Louisiana 70112, United States

Univ of North Carolina School of Medicine / Div Hemat / Onco, Chapel Hill, North Carolina 275997035, United States

Milton Hershey Med Ctr, Hershey, Pennsylvania 170330850, United States

Montreal Gen Hosp, Montreal, Quebec, Canada

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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