Evaluation of a Therapeutic Immunization Strategy Associating a DNA Vaccine (GTU-MultiHIV B) Followed by a Lipopeptide Vaccine (LIPO-5) in the Control of Viral Replication Following Antiretroviral Treatment Interruption in HIV-1 Infected Patients With a CD4 Cell Count ≥ 600/mm3
Inclusion Criteria
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
- 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 48 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 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.