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
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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: 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
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