Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002430
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label 24-Week Study to Compare the Safety and Activity of Indinavir Sulfated4T3TC Versus Indinavir SulfateNelfinavir Mesylated4T3TC in HIV-Infected Individuals
Status:
COMPLETED
Status Verified Date:
2000-02
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 compare two different anti-HIV drug combinations one that contains nelfinavir NFV and one that does not The best dosing schedule for indinavir IDV also will be studied
Detailed Description:
Patients are stratified by screening plasma viral RNA results 50000 copiesml or below vs above 50000 copiesml and randomized to 1 of 2 treatment arms Group 1 receives IDV 3 times daily plus d4T3TC twice daily Group 2 receives IDVNFVd4T3TC twice daily Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study At each clinic visit blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels
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 |
|---|---|---|---|
| CRX454 | None | None | None |
| 079-02 | None | None | None |