Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients (VIH-2)
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|ClinicalTrials.gov Identifier: NCT01605890|
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV-2 Infection||Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 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.
- Percentage 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
- Median Change in CD4 Lymphocytes Count at Week 12 [ Time Frame: between Week 0 and Week 12 ]
- Number of Clinical and Biological Events [ Time Frame: from Week 0 to Week 48 ]
- Median Change of CD4 Lymphocytes at Week 48 [ Time Frame: between Week 0 and Week 48 ]
- Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL [ Time Frame: between Week 0 and Week 48 ]
- Number of Participants With Clinical Progression [ Time Frame: from Week 0 to Week 48 ]
Clinical progression is defined as the switch:
- from category A to B, C or death.
- from category B to C or death.
- Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence [ Time Frame: from Week 4 to Week 48 ]
- Number of Virological Failure Participants With Resistance Mutations [ Time Frame: from Week 0 to Week 48 ]Virological failure is defined as 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. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported.
- Number of Participants With Treatment Switch or Discontinuation [ Time Frame: from Week 0 to Week 48 ]Overall (regardless of the molecule)
- Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48 [ Time Frame: at Week 48 ]
- Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire [ Time Frame: from Week 0 to Week 48 ]
The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:
Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated.
- Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24 [ Time Frame: Week 24 ]
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|