Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002451
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-01-17
Brief Title:
Safety and Effectiveness of Giving Indinavir Ritonavir Stavudine and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg qd and Ritonavir 200 Mg qd in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients
Status:
UNKNOWN
Status Verified Date:
2002-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 it is safe to give indinavir IDV and ritonavir RTV in combination with stavudine d4T and lamivudine 3TC to HIV-positive patients who have never received anti-HIV therapy This study will look at the effectiveness of this drug combination and side effects
Detailed Description:
Patients entering this study initiate antiretroviral therapy For 24 weeks patients receive daily dosages of IDV RTV 3TC and d4T Patients are seen at Day 1 and at Weeks 2 4 8 12 16 20 and 24 for physical examinations pregnancy testing and blood sampling to monitor CD4 count and viral load On Day 14 blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated
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 |
|---|---|---|---|
| 104-00 | None | None | None |