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Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia Clinical research trials and Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia. Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia clinical trial. Human subjects often get the best healthcare possible for their Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia  Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia
Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia
For Condition: HIV Infections,Hemophilia A
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Male
Protocol Entry 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).
Total Enrollment: 55
Location and Contact Information:
Emory Univ
Atlanta, Georgia, 30322
United States
Georgetown U Med Ctr / Div of Hematology / Oncology
Washington D.C., District of Columbia, 20007
United States
Montreal Gen Hosp
Montreal, Quebec,
Canada
Milton Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Riley Hosp for Children
Indianapolis, Indiana, 462025225
United States
USCF
San Francisco, California, 94143
United States
Tulane Univ School of Medicine / Hematology / Oncology
New Orleans, Louisiana, 70112
United States
Univ of North Carolina School of Medicine / Div Hemat / Onco
Chapel Hill, North Carolina, 275997035
United States
Additional Information:
Study ID Numbers: 246J; 065-00
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002386
Other Hiv Infections Studies:
1. Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
2. A Study of DPC 817 in HIV-Infected Males
3. A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
4. Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
5. A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Hershey Clinical Trials
Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males with Hemophilia
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