New hope for rare HIV-2: drug combo shows promise

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age ≥18 years * HIV-2 mono infection, confirmed by ELISA and Western Blot test or Immunoblot, * antiretroviral treatment-naive, whatever the duration and indication of prior treatments, * indication to treatment, with at least one of the following criteria : type B or C events, CD4 lymphocytes count below 500/mm3 at screening-visit or CD4 lymphocytes count decrease of at least 50 cell/µL/year over the last 3 years with the last CD4 lymphocytes count within -/+ 10 % of the nadir, plasma HIV-2 RNA load over or equal to 100 copies/mL at screening-visit, * Pneumocystis prophylaxis if CD4 lymphocytes count below 200/mm3, combined to a toxoplasmosis prophylaxis in case of a positive toxoplasmosis serology, * French residency for at least one year, * Written informed consent, signed by the participant and the investigator (at the latest on the screening-visit and prior any study related intervention) * Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme). Exclusion Criteria: * Absence of effective contraception method(women), * Pregnancy, breastfeeding or wish for pregnancy during the trial, * Curative treatment of a progressive opportunistic infection not compatible with those evaluated in the present study, * Malignant or tumorous affection requiring chemotherapy or radiotherapy, * Decompensated cirrhosis, * Viral hepatitis C with a Metavir score over F2, * Hemoglobinemia below 7g/dL, polynuclear neutrophils below 500/mm3, platelets below 50 000/mm3, creatinine clearance below 50 mL/mn, transaminase, alkaline phosphatase or bilirubin over 2.5N, * Contraindication to one of the excipients of study treatments, * Insuline-dependent diabetes mellitus not well controlled (with glycated haemoglobin (HbA1C) over 7%), * Long-term corticosteroid treatment (more than 3 weeks of treatment), * Judicial protection, legal guardianship, * Participation in other therapeutic trial or comprising an exclusion period ongoing at the time of the screening-visit.