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

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ClinicalTrials.gov Identifier: NCT00002386
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Hemophilia A Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Primary Purpose: Treatment
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

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002386

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

ClinicalTrials.gov Identifier: NCT00002386     History of Changes
Other Study ID Numbers: 246J
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Factor VIII
Factor IX
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Platelet Aggregation
Hemophilia A
Hemophilia B

Additional relevant MeSH terms:
HIV Infections
Hemophilia A
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents