The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensitivity to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Hôpital Bichat-Claude Bernard
Paris, France
Percentage of Participants in Therapeutic Success
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
Time frame: at Week 48
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
Clinical progression is defined as the switch: * from category A to B, C or death. * from category B to C or death.
Time frame: from Week 0 to Week 48
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
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.
Time frame: from Week 0 to Week 48
Number of Participants With Treatment Switch or Discontinuation
Overall (regardless of the molecule)
Time frame: from Week 0 to Week 48
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
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.
Time frame: from Week 0 to Week 48
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
Time frame: Week 24
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