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

This study has been completed.

Sponsored by: Merck
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002386
  Purpose

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

Genetics Home Reference related topics:   hemophilia   

MedlinePlus related topics:   AIDS    AIDS Medicines    Hemophilia   

ChemIDplus related topics:   Zidovudine    Lamivudine    Indinavir    Indinavir Sulfate    Didanosine    Stavudine    Zalcitabine    Factor IX    Factor VIII    Octocog alfa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   55

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
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002386

Locations
United States, California
USCF    
      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
  More Information


Study ID Numbers:   246J, 065-00
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002386
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
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

Study placed in the following topic categories:
Hemophilia B
Sexually Transmitted Diseases, Viral
Stavudine
Indinavir
Hematologic Diseases
Blood Coagulation Disorders
Zalcitabine
Acquired Immunodeficiency Syndrome
Hemophilia A
Lamivudine
Zidovudine
Hemostatic Disorders
Factor VIII
Immunologic Deficiency Syndromes
Virus Diseases
Didanosine
Hemorrhagic Disorders
Genetic Diseases, Inborn
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Coagulation Protein Disorders
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Blood Coagulation Disorders, Inherited
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2008




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