Clinical trial NCT00002386: Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Hemophilia A
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Indinavir
Factor VIII
Factor IX
Half-Life
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Platelet Aggregation
Hemophilia A
Hemophilia B
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 55
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: USCF
state: California
city: Washington
country: United States
facility: Georgetown U Med Ctr / Div of Hematology / Oncology
state: District of Columbia
city: Atlanta
country: United States
facility: Emory Univ
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hosp for Children
state: Indiana
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine / Hematology / Oncology
state: Louisiana
city: Chapel Hill
country: United States
facility: Univ of North Carolina School of Medicine / Div Hemat / Onco
state: North Carolina
city: Hershey
country: United States
facility: Milton Hershey Med Ctr
state: Pennsylvania
city: Montreal
country: Canada
facility: Montreal Gen Hosp
state: Quebec
Study officials:
References: