Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460382
Status:
COMPLETED
Last Update Posted:
2010-09-17
First Post:
2007-04-12
Brief Title:
Clinical Trial to Assess the Efficacy of DarunavirRitonavir DRVr Etravirine ETV and Raltegravir MK-0518 in HIV Patients With Resistant Viruses
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Prospective Clinical Trial to Assess Safety and Efficacy of DRVrTMC 114r ETVTMC 125 and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO
Status:
COMPLETED
Status Verified Date:
2010-09
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:
ANRS139 TRIO
Brief Summary:
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs darunavir etravirine and MK-0518 raltegravir in patients who have multi-resistant viruses and limited treatment options An optimized background regimen that may include nucleoside reverse transcriptase inhibitors NRTIs and enfuvirtide can be added if possible to this combination Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24
Detailed Description:
Methods A phase II pilot prospective open label single arm multicentric clinical trial assessing a darunavirritonavir etravirine and MK-0518-containing regimen if possible associated to an optimized background regimen that may include NRTIs and enfuvirtide in HIV-1 infected patients failing combination antiretroviral therapy with multi-resistant viruses
Treatment strategy Patients will receive raltegravir MK-0518 darunavirritonavir TMC114r and etravirine TMC125 and if possible an optimized background therapy
raltegravir MK-0518 400 mg x 2d one 400 mg pill twice daily
darunavir 600 mg x 2d two 300 mg pills twice daily with meal
ritonavir 100 mg x 2d one 100 mg pill twice daily with meal
etravirine 200 mg x 2d two 100 mg pills twice daily with meal
if possible an optimized background therapy may include NRTIs and enfuvirtide but not nonnucleoside reverse transcriptase inhibitors NNRTIs and protease inhibitors PIs NRTIs choice is left to the clinicians discretion Enfuvirtide is highly recommended in enfuvirtide-naive patients but is left to the clinician
Main outcome proportion of patients with HIV RNA levels of less than 50 copiesml in an intent to treat analysis at W24
Secondary outcomes proportions of patients with HIV RNA levels of less than 50 copiesml at week 48 with HIV RNA levels of less than 400 copiesml at week 24 and 48 HIV RNA level evolution between baseline and week 48 HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48 number and type of resistance mutations in case of virologic failure occurrence CD4 lymphocyte count and proportion evolution between baseline and week 48 HIV infection progression frequency of the study regimen modifications and interruption study regimen tolerance study regimen adherence association between study drugs minimum concentrations at week 4 and virologic success at week 24 evolution of pharmacokinetic parameters of study drugs between week 1 and week 4 in the Pharmacokinetic substudy
Sample size 103 patients
Enrollment period 24 weeks
Patients participation duration 52 weeks
An extended follow-up from week 52 to week 96 has been added in April 2008
Treatment strategy Patients will receive raltegravir MK-0518 darunavirritonavir TMC114r and etravirine TMC125 and if possible an optimized background therapy
raltegravir MK-0518 400 mg x 2d one 400 mg pill twice daily
darunavir 600 mg x 2d two 300 mg pills twice daily with meal
ritonavir 100 mg x 2d one 100 mg pill twice daily with meal
etravirine 200 mg x 2d two 100 mg pills twice daily with meal
if possible an optimized background therapy may include NRTIs and enfuvirtide but not nonnucleoside reverse transcriptase inhibitors NNRTIs and protease inhibitors PIs NRTIs choice is left to the clinicians discretion Enfuvirtide is highly recommended in enfuvirtide-naive patients but is left to the clinician
Main outcome proportion of patients with HIV RNA levels of less than 50 copiesml in an intent to treat analysis at W24
Secondary outcomes proportions of patients with HIV RNA levels of less than 50 copiesml at week 48 with HIV RNA levels of less than 400 copiesml at week 24 and 48 HIV RNA level evolution between baseline and week 48 HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48 number and type of resistance mutations in case of virologic failure occurrence CD4 lymphocyte count and proportion evolution between baseline and week 48 HIV infection progression frequency of the study regimen modifications and interruption study regimen tolerance study regimen adherence association between study drugs minimum concentrations at week 4 and virologic success at week 24 evolution of pharmacokinetic parameters of study drugs between week 1 and week 4 in the Pharmacokinetic substudy
Sample size 103 patients
Enrollment period 24 weeks
Patients participation duration 52 weeks
An extended follow-up from week 52 to week 96 has been added in April 2008
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS 139 TRIO | None | None | None |