Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients (VIH-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01605890|
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV-2 Infection||Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605890
|Hôpital Bichat-Claude Bernard|
|Paris, France, 75018|
|Study Chair:||Sophie Matheron, Pr||Hopital Bichat-Claude Bernard|