Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002443
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of MK-639 and Zidovudine Used Alone and Together in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of MK-639 and Zidovudine AZT Administered Concomitantly to MK-639 Alone and Zidovudine AZT Alone
Status:
COMPLETED
Status Verified Date:
1996-09
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:
To compare the effects on CD4 counts and safety of MK-639 indinavir IDV and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients
Detailed Description:
Patients are randomized to 1 of 3 groups for 12 months of treatment Group 1 receives MK-639 plus AZT Group 2 receives MK-639 alone Group 3 receives AZT alone Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639
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?: