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.

Condition	Treatment or Intervention	Phase
HIV Infections Hemophilia A	Drug: Indinavir sulfate  Drug: Lamivudine  Drug: Stavudine  Drug: Zidovudine  Drug: Zalcitabine  Drug: Didanosine	Phase IV

Further Study Details: 

Expected Total Enrollment:  55

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  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).

California
      USCF, San Francisco,  California,  94143,  United States
District of Columbia
      Georgetown U Med Ctr / Div of Hematology / Oncology, Washington,  District of Columbia,  20007,  United States
Georgia
      Emory Univ, Atlanta,  Georgia,  30322,  United States
Indiana
      Riley Hosp for Children, Indianapolis,  Indiana,  462025225,  United States
Louisiana
      Tulane Univ School of Medicine / Hematology / Oncology, New Orleans,  Louisiana,  70112,  United States
North Carolina
      Univ of North Carolina School of Medicine / Div Hemat / Onco, Chapel Hill,  North Carolina,  275997035,  United States
Pennsylvania
      Milton Hershey Med Ctr, Hershey,  Pennsylvania,  170330850,  United States
Canada, Quebec
      Montreal Gen Hosp, Montreal,  Quebec,  Canada

Study ID Numbers:  246J; 065-00
Record last reviewed:  June 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002386
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08