Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients (VIH-2)
|HIV-2 Infection||Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients|
- Proportion of participants in therapeutic success [ Time Frame: at Week 48 ]
The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:
- Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,
- CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,
- Raltegravir permanent discontinuation,
- Death from any cause,
- New B or C events confirmed by an endpoint review committee
- Gain in CD4 lymphocytes count [ Time Frame: between Week 0 and Week 12 ]
- Tolerance of the treatment [ Time Frame: from Week 0 to Week 48 ]
- number, nature, severity and time to adverse event.
- evolution of the metabolic disorders, clinical and biological measurement
- Evolution of the number and percentage of CD4 lymphocytes [ Time Frame: between Week 0 and Week 48 ]
- Evolution of plasma HIV-2 RNA load [ Time Frame: between Week 0 and Week 48 ]
- The rate of clinical progression will be defined as the switch [ Time Frame: from Week 0 to Week 48 ]
- from category A to B, C or death.
- from category B to C or death.
- Adherence evaluated with ANRS self-administered questionnaire of adherence and plasma measurements of residual concentrations of antiretroviral drugs in viral failure cases [ Time Frame: from Week 0 to Week 48 ]
- Description of the resistance mutations'profile in virological failure cases [ Time Frame: from Week 0 to Week 48 ]
Description of the resistance mutations'profile in virological failure cases (plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks) with:
- the number and type of mutations in the RT and integrase genes compared to Week 0.
- the evolution of the phenotypic sensitivity of raltegravir and NRTIs compared to Week 0
- Frequency of treatment switch or discontinuation [ Time Frame: from Week 0 to Week 48 ]
- overall (regardless of the molecule).
- for each study drug (raltegravir and emtricitabine/tenofovir disoproxil fumarate combination).
- Evolution of plasma HIV-2 DNA load in PBMC [ Time Frame: at Week 24 and Week 48 and compared to those performed at Week 0 ]
- Evolution of the quality of life [ Time Frame: from Week 0 to Week 48 ]through PROQOL questionnaire
|Study Start Date:||July 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: raltegravir / emtricitabine / tenofovir disoproxil fumarate||
Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .
emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.
raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605890
|Hôpital Bichat-Claude Bernard|
|Paris, France, 75018|
|Study Chair:||Sophie Matheron, Pr||Hopital Bichat-Claude Bernard|