Status:
COMPLETED
Lipopeptide Immunisation With GTU-multiHIV Trial
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is expected to induce strong and diverse HIV-specific immune responses in HIV-infected patients. The investigators w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2017
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01492985
Start Date
July 1 2013
End Date
April 8 2017
Last Update
July 5 2019
Active Locations (1)
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1
Service d'Immunologie clinique, Centre de vaccination anti-VIH ANRS Mondor Ile-de-France, Hôpital Henri Mondor
Créteil, France, 94010