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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


Phase 2
18 Years
59 Years
Not Enrolling
Both
HIV-1 Infection

Thank you

Trial Information

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Plasma HIV-1 RNA level

Outcome Time Frame:

week 48 (W48)

Safety Issue:

No

Principal Investigator

Yves Lévy, PU-PH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Henri Mondor - Créteil - France

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2009-018198-30

NCT ID:

NCT01492985

Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • HIV-1 Infection
  • HIV Infections

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