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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002386
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002386     History of Changes
Other Study ID Numbers: 246J, 065-00
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on October 29, 2014