Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002386
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
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 VIIIIX Half-Life in HIV-1 Seropositive Patients With Hemophilia A or B
Status:
COMPLETED
Status Verified Date:
1999-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 065-00 | None | None | None |