Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators:
Gilead Sciences Merck Sharp & Dohme Corp.
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Raltegravir Potassium Tenofovir