Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002406
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors NRTIs in HIV-Infected Patients
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label Randomized 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate 800 Mg q 8h Versus 1200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 CopiesMl on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors NRTI
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 determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors NRTIs have the same effect on plasma viral load level of HIV in the blood
Detailed Description:
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA less than 400 copiesmL vs negative plasma viral RNA result then randomized into one of two arms
Arm 1 Indinavir 800 mg q8h plus two pre-existing NRTIs Arm 2 Indinavir 1200 mg q12h plus two pre-existing NRTIs Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study
Arm 1 Indinavir 800 mg q8h plus two pre-existing NRTIs Arm 2 Indinavir 1200 mg q12h plus two pre-existing NRTIs Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week 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 |
|---|---|---|---|
| MK-0639 | None | None | None |