Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006211
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Double-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 see if the addition of capravirine to VIRACEPT nelfinavir mesylate plus 2 nucleoside reverse transcriptase inhibitors NRTIs is an effective combination drug therapy for HIV patients who have failed a nonnucleoside reverse transcriptase inhibitor NNRTI therapy
Detailed Description:
Note As of 2282001 due to toxicity studies and concern for safety patients need to sign new informed consents 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 This study will take place in approximately 150 centers in the US Canada Europe Australia Argentina and South Africa Patients are randomized to 1 of 2 treatment groups and stratified by geographic sites North American and non-North American plasma HIV-1 RNA levels and prior NNRTI use Group 1 patients receive capravirine plus VIRACEPT plus 2 new NRTIs and Group 2 patients receive capravirine placebo plus VIRACEPT plus 2 new NRTIs NRTIs will not be provided by the sponsor Patients may remain on their assigned treatment for 48 weeks with posttherapy follow-up occurring at 1 and 3 months Assessments done at various times throughout the study include medical history HIV antibody test complete or symptom-directed physical examination vital signs height weight serum pregnancy test hematology chemistry and recording of concomitant medications and adverse events Other select assessments are performed at specified visits Plasma samples for resistance testing and blood specimens for peripheral blood mononuclear cells PBMC are obtained at several times The plasma samples and PBMCs may be used for viral drug resistance testing Blood samples for quantitation of capravirine VIRACEPT and M8 a metabolite of VIRACEPT plasma concentrations are collected several times Additional blood samples for analysis of drug concentrations may be requested depending on concomitant NRTIs or other medications A Data Safety Monitoring Board monitors patient safety at prescribed intervals during the 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 |
|---|---|---|---|
| AG1549-508 | None | None | None |