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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002386
• Other study ID #: 246J
• Secondary ID: 065-00
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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).

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A
• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Lamivudine

• Stavudine

• Zidovudine

• Zalcitabine

• Didanosine

Locations

Country	Name	City	State
Canada	Montreal Gen Hosp	Montreal	Quebec
United States	Emory Univ	Atlanta	Georgia
United States	Univ of North Carolina School of Medicine / Div Hemat / Onco	Chapel Hill	North Carolina
United States	Milton Hershey Med Ctr	Hershey	Pennsylvania
United States	Riley Hosp for Children	Indianapolis	Indiana
United States	Tulane Univ School of Medicine / Hematology / Oncology	New Orleans	Louisiana
United States	USCF	San Francisco	California
United States	Georgetown U Med Ctr / Div of Hematology / Oncology	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Canada,