Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 2:09 PM
Study NCT ID:
NCT01291459
Status:
UNKNOWN
Last Update Posted:
2015-12-30
First Post:
2011-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients
Sponsor:
Association Pour la Recherche en Infectiologie
Organization:
Study Overview
Official Title:
Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus
Status:
UNKNOWN
Status Verified Date:
2015-12
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:
NNNB
Brief Summary:
Background and Rationale
Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.
Hypothesis
Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.
Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.
Hypothesis
Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.
Detailed Description:
Objectives:
* To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load \< 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)
* To study CD4 progression from baseline to week 48
* To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)
* To study the proportion of patients with HIV RNA \< 50 copies/ml at each time point
* To study the kinetics of viral load decrease from baseline to week 12
* To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48
* To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48
Study Design/ Clinical Plan
Pilot, multicenter, national, uncontrolled study
* To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load \< 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)
* To study CD4 progression from baseline to week 48
* To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)
* To study the proportion of patients with HIV RNA \< 50 copies/ml at each time point
* To study the kinetics of viral load decrease from baseline to week 12
* To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48
* To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48
Study Design/ Clinical Plan
Pilot, multicenter, national, uncontrolled study
Study Oversight
Has Oversight DMC:
True
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?: