Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004985
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-03-15
Brief Title:
Combination Treatment Using Capravirine AG1549 Nelfinavir and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Single-Blind Randomized Placebo-Controlled Study of Capravirine AG1549 in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
Status:
COMPLETED
Status Verified Date:
2001-03
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 look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment
Detailed Description:
Note As of 2282001 due to toxicity studies and concern for safety changes in the methodology were implemented and patients need to sign new informed consents The study is unblinded Group 1 receives AG1549 Group 2 receives an AG1549 placebo Patients who are taking capravirine and who currently have viral loads below 400 copiesml may continue to take capravirine at 1400 mg twice daily Capravirine will be discontinued in patients with viral loads greater than 400 copiesml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators Both groups also receive nelfinavir mesylate and 2 NRTIs All patients receive the same dose of nelfinavir mesylate The NRTIs are selected at the investigators discretion provided the patient has not previously received the chosen NRTIs Patients have regular physical examinations Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA pharmacokinetics and CD4 and CD8 counts Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation
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 |
|---|---|---|---|
| AG1549-509 | None | None | None |