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HIV-1 InfectionPhase 2NCT01492985

Lipopeptide Immunisation With GTU-multiHIV Trial

A Phase 2 study testing GTU-multHIV B vaccine and LIPO-5 vaccine in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 will carry out the clinical therapeutic immunization "proof of concept" trial in HIV infected patients. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
HIV-1 Infection
What is being tested?
GTU-multHIV B vaccine and LIPO-5 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteFrance
Study dates
Jul 2013to 8 Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service d'Immunologie clinique, Centre de vaccination anti-VIH ANRS Mondor Ile-de-France, Hôpital Henri Mondor

    Créteil, 94010

Other trials in France

About this study

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.

Read more

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.

Conditions
HIV-1 Infection
Being tested
Placebos of GTU-multiHIV B and LIPO-5 vaccines, GTU-multHIV B vaccine and LIPO-5 vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebos of GTU-multiHIV B and LIPO-5 vaccinesBiological

    Placebos corresponds respectively to 1X PBS pH = 7.2 and glucose 5%

  • GTU-multHIV B vaccine and LIPO-5 vaccineBiological

    Vaccines are respectively an HIV-DNA plasmid and a mixture of 5 HIV-lipopeptides.

Study groups in NCT01492985
Study groupRoleWhat they receive
Vaccine placebosPlacebo comparatorVaccine placebos corresponding to the dilutant of these vaccines
Receives: Biological: Placebos of GTU-multiHIV B and LIPO-5 vaccines
Vaccine armExperimentalNot described
Receives: Biological: GTU-multHIV B vaccine and LIPO-5 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma HIV-1 RNA level

    Measured: week 48 (W48)

Secondary outcomes (13)

  1. Plasma HIV-RNA after stopping antiviral treatment

    Measured: W40, W44, W48 and W74

  2. Percentage of patients with plasma HIV-RNA below 10 000 copies/mL

    Measured: W48

  3. Ultrasensitive proviral DNA

    Measured: W-3, W20, W32 and W44

  4. CD4 T cell counts

    Measured: W40, W44 and W48 or prior HAART resumption and W74

  5. Percentages of patients who resumed HAART

    Measured: between W36 and W48

  6. Percentages of patients who reached CD4 cell counts < 350/mm3 confirmed two weeks apart

    Measured: between W36 and W48

  7. Strength of HIV-specific CD4/CD8 responses

    Measured: W0, W16, W28, W48 or at the time of failure anw W74

  8. Proportion of responders to at least one HIV peptide pool

    Measured: W0, W16, W28, W48 or at the time of failure and W74

  9. Breadth of CD4/CD8+ HIV-specific responses defined as the number of HIV pools recognized among the 18 pools

    Measured: W0, W16, W28, W48 or at the time of failure and W74

  10. Polyfunctionality of HIV specific T cell responses evaluated by the mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFN-g following ex-vivo stimulation with HIV-1 peptide pools

    Measured: W0, W16, W28, W48 and W74

  11. Adverse Events > grade 2

    Measured: W0, W4, W12, W16, W20, W24, W28, W32, W36, W38, W40, W42, W44, W48 and W74

  12. AIDS-defining events and serious non-AIDS events defined as cardiovascular diseases, kidney diseases, end stage liver diseases, non-AIDS defining malignancies except basal cellular skin cancer, and bacterial infections

    Measured: W0, W4, W12, W16, W20, W24, W28, W32, W36, W38, W40, W42, W44, W48 and W74

  13. Analysis of predictive factors for plasma HIV-RNA

    Measured: W48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2016
  4. Study completion8 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492985
Sponsor's protocol ID
2009-018198-30
Other IDs
ANRS 149 LIGHT, 2009
Status last verified
Feb 2018
First submitted
24 Nov 2011
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Alexandre M, Prague M, Lhomme E, Lelievre JD, Wittkop L, Richert L, Levy Y, Thiebaut R. Definition of Virological Endpoints Improving the Design of HIV Cure Strategies Using Analytical Antiretroviral Treatment Interruption. Clin Infect Dis. 2024 Dec 17;79(6):1447-1457. doi: 10.1093/cid/ciae235.

    PubMed 38819800

  • Levy Y, Lacabaratz C, Lhomme E, Wiedemann A, Bauduin C, Fenwick C, Foucat E, Surenaud M, Guillaumat L, Boilet V, Rieux V, Bouchaud O, Girard PM, Molina JM, Morlat P, Hocqueloux L, Richert L, Pantaleo G, Lelievre JD, Thiebaut R. A Randomized Placebo-Controlled Efficacy Study of a Prime Boost Therapeutic Vaccination Strategy in HIV-1-Infected Individuals: VRI02 ANRS 149 LIGHT Phase II Trial. J Virol. 2021 Apr 12;95(9):e02165-20. doi: 10.1128/JVI.02165-20. Print 2021 Apr 12.

    PubMed 33568510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GTU-multHIV B vaccine and LIPO-5 vaccine in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma HIV-1 RNA level (time frame: week 48 (W48)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492985, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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