Lipopeptide Immunisation With GTU-multiHIV Trial

Inclusion criteria

• Documented HIV-1 infection (ELISA and Western blot)
• Age ≥ 18 years and < 60 years
• No history of CDC category C clinical events (1993), including cutaneous Kaposi's sarcoma
• CD4 Nadir ≥ 300/mm3 Under antiretroviral treatment
• CD4 ≥ 600/mm3 on all measurements within the previous 6 months* prior to W-3 screening visit (one single CD4 value between 550-600 cells/ mm3 is permitted)
• CD4 value ≥ 600/ mm3 at W-3 screening visit
• Plasma HIV1-RNA < 50 copies/mL on all measurements within the previous 6 months* (An occasional measurement of HIV-1 RNA (so-called " blip " between 50 and 200 copies/mL is permitted)
• HIV1-RNA < 50 copies/mL at W-3 screening visit

• In the absence of measurement in the last 6 months, a measurement performed in the last 12 months is accepted
• Treatment with a combination of antiviral drugs (cART) for at least 18 months regardless of the combination, under condition that :

• in the W24 visit the non-nucleoside inhibitors are replaced by a protease inhibitor potentiated by ritonavir
• no failure or resistance to the protease inhibitor was previously reported
• With adequate method of contraception and negative pregnancy test (βHCG plasma) for women of childbearing potential
• Laboratory parameters at W-3:

• polynuclear neutrophils ≥ 1,000/mm3
• haemoglobin ≥ 10 g/dl
• platelets ≥ 100,000/mm3
• creatinine ≤ 1.5 x N
• AST, ALT, bilirubin ≤ 2.5 x N
• proteinuria ≤ 1 g/L (++)
• anti-nuclear antibodies ≤ 1/320
• anticardiolipin antibodies ≤ 30 U
• no lupus anticoagulant
• Participant agreeing to be treated and followed for at least 74 weeks according to the protocol
• Participant agreeing to interrupt his/her cART treatment and, if applicable, to replace the non-nucleoside inhibitors by a protease inhibitor potentiated by ritonavir at W24
• Participant agreeing to the use of condom, in particular during ART interruption period (between the visit S36 and the visite S48)
• Participant covered by HealthInsurance (article L1121-11 of Code de la Santé Publique)
• Written informed consent (at the latest the day of pre-inclusion and before all exams to be done in the context of the trial) (article L1122-1-1 of Code de la Santé Publique).

Exclusion criteria

• Pregnancy or lactation,
• HIV-2 infection (isolated or associated with HIV-1),
• History of (experimental) vaccinations against HIV,
• Treatment with chemotherapy or interferon alpha (IFN-α-2b), sargramostim (GM-CSF), IL-2 or IL-7 ongoing or in the previous12 weeks before inclusion (W0),
• Treatment with corticoids or immunosuppressive agents ongoing or in the previous12 weeks before inclusion in the trial (W0),
• Administration of a live vaccine within 60 days prior to inclusion in the trial (W0) or any other inactivated vaccine within 14 days before W0 visit
• Planned administration, during the follow-up of participants, of a vaccine other than those recommended in France as part of the usual care of patients
• History of cancer (except basal cellular skin carcinoma),
• History of cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke),
• History of renal failure related to HIV,
• History of thrombocytopenia related to HIV (<50,000/mm3),
• Ongoing cardiac, pulmonary, thyroid, renal or neurological (peripheral or central) diseases,
• Progressive infection,
• Co-infection with hepatitis B (HBsAg + or isolated anti-HBc antibodies +) or hepatitis C (anti-HCV antibody and PCR +),
• Known allergy to aminoglycosides,
• Person placed under juridical protection (article L1122-2 of Code de la Santé Publique)
• Person participating in another biomedical research with an exclusion period always ongoing at screening.