HIV-1 Infection Clinical Trial
Official title:
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
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 will carry out the clinical therapeutic immunization "proof of concept"
trial in HIV infected patients. The investigators propose a multi-center double blind
randomized versus placebo phase II clinical trial in patients who are chronic asymptomatic
HIV-infected patients, with undetectable viral load while treated with a potent combination
of antiviral drugs. Patients will continue antiviral therapy combined with either therapeutic
vaccination or placebo vaccination. Patients will undergo the procedure which includes a
prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM injections via
Biojector (a needle-free injection system) followed by a boost of LIPO-5 vaccine or placebo
also given IM.
In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine
arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or
its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2
doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost
vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48.
Patients will be intensely monitored during the treatment interruption period. After start of
cART treatment (at the latest in W48), a data collection from clinical car will be carried
out. A blood sample with W74 will allow to study the persistence ot the immunizing responses,
1 year after the injection of the last vaccine/placebo.
The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after
stopping all antiviral treatment).
The main hypothesis for conducting a phase II randomized trial is that immune responses in
vaccinated patients may be associated with a better control of viral replication following
c-ART interruption as compared to placebo-vaccinated patients.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03188523 -
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
|
Phase 1 | |
| Active, not recruiting |
NCT06185452 -
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
|
Phase 4 | |
| Recruiting |
NCT02881320 -
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02513771 -
Sitagliptin for Reducing Inflammation and Immune Activation
|
Phase 2 | |
| Completed |
NCT02542852 -
A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia
|
Phase 2 | |
| Terminated |
NCT02732457 -
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
|
||
| Completed |
NCT02057796 -
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
|
Phase 4 | |
| Completed |
NCT01989910 -
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
|
Phase 4 | |
| Completed |
NCT01627678 -
Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
|
Phase 1/Phase 2 | |
| Completed |
NCT01704781 -
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
|
Phase 1/Phase 2 | |
| Completed |
NCT01403051 -
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
|
Phase 2 | |
| Completed |
NCT01466595 -
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
|
Phase 2 | |
| Completed |
NCT01348308 -
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
|
Phase 3 | |
| Completed |
NCT01019551 -
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
|
Phase 2 | |
| Completed |
NCT01511809 -
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
|
Phase 3 | |
| Terminated |
NCT01130376 -
Novel Interventions in HIV-1 Infection
|
Phase 1 | |
| Completed |
NCT00323687 -
SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
|
Phase 4 | |
| Completed |
NCT04003103 -
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
|
Phase 2 | |
| Completed |
NCT02527096 -
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
|
Phase 2 | |
| Active, not recruiting |
NCT04776252 -
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
|
Phase 3 |