Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01291459
Status:
UNKNOWN
Last Update Posted:
2015-12-30
First Post:
2011-01-26
Brief Title:
Pilot Study of MaravirocRaltegravir for Naive HIV-1 Patients
Sponsor:
Association Pour la Recherche en Infectiologie
Organization:
Association Pour la Recherche en Infectiologie
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 copiesml 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 copiesml 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 copiesml 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 copiesml 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:
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