Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT01291459
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.
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
Study:
NCT01291459
Study Brief:
Protocol Section:
NCT01291459