Testing antibodies with ART for early HIV infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RHIVIERA-02 trial is a phase II, placebo-controlled, double-blinded study that aims to evaluate the effectiveness of dual long-acting broadly neutralizing antibodies (bNAbs) combined with antiretroviral therapy (ART) in individuals diagnosed with primary HIV-1 infection. Participants will receive either the bNAbs plus ART or a placebo plus ART, and will be monitored for HIV-1 replication. The study plans to enroll 69 participants across various clinical centers in the Ile-de-France region of France, with ART interruption occurring 52 weeks after initiation. The primary goal is to assess the impact of the bNAbs on post-ART viral control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed primary HIV-1 infection diagnostic
* Aged ≥18 to ≤70 years old at screening
* Willing to use use an effective method of contraception from the inclusion until the end of the follow-up in the trial
* Negative plasmatic beta human chorionic gonadotropin (β-HCG) pregnancy test, when applicable
* Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit, when applicable
* Informed and written signed consent
* Participant with regular health insurance
* Willing to accept the trial constraints (travel for IMP administration and ART interruption)
* Willing to be vaccinated against COVID-19 according to recommandations

Exclusion Criteria:

* Participation in any other clinical trial requiring additional blood sampling Participation in an observational study without additional blood sampling is permitted
* Participants in whom condom use or PrEP use by the partner will be difficult or impossible
* Pregnant or breastfeeding patient
* Participants under guardianship or curatorship
* Any condition or infection, including HCV, HBV, SARS-CoV-2 or known M. tuberculosis active infection History of ischemic heart disease (myocardial infarction, stable or unstable angina, stroke)
* Current or past history of cancer, excluding squamous cell skin cancers
* History or acute known inflammatory ophthalmic affection (uveitis, choroiditis, optic neuropathy)
* Any medical condition that contraindicates ART interruption
* Concomitant or previous conditions that preclude injection of monoclonal antibodies
* History of systemic corticosteroids, immunosuppressive and anti-cancer medications within the last 6 months
* History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions
* Individuals with any contraindication (including hypersensitivity reaction) to 3BNC117-LS and 10-1074-LS infusion
* Prothrombin \< 50%
* Creatinine clearance \< 60mL/mn (Cockroft)
* ASAT or ALAT or bilirubine (total et conjugated) ≥ 10 times the upper limit of normal
* Patient with an isolated HIV-2 viral strain
* Planned absence that could affect participation in the trial (travel abroad, relocation, impending transfer...)

Where it's running

• Hôpial Avicenne - SMIT
  Bobigny, France Recruiting
• Hôpital Antoine Béclère
  Clamart, France Recruiting
• Hôpital Beaujon - Service de médecine interne
  Clichy, France Recruiting
• CHI Créteil - HdJ
  Créteil, France Recruiting
• Hôpital Raymond Poincaré - SMIT
  Garches, France Recruiting
• Hôpital Bicêtre - HdJ - Médecine interne
  Le Kremlin-Bicêtre, France Recruiting

Study contacts

• Principal investigator: Cécile Goujard, Pr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Mathilde Ghislain, MSc
• Email: mathilde.ghislain@inserm.fr
• Phone: +331 45 59 52 29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.