Testing antibodies with ART for early HIV infection
A Randomised Phase II Placebo-controlled Trial of Antiretroviral Therapy (ART) Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo During Primary HIV-1 Infection to Study the Impact on Post-treatment HIV Control.
This study is testing whether a new combination of long-acting antibodies and HIV medication can help people with early HIV infection control the virus better after stopping the medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 17 sites (Bobigny and 16 other locations) |
| Trial ID | NCT05300035 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with primary HIV-1 infection who are willing to participate in the trial and adhere to its requirements.
Not a fit: Patients who are not in the early stages of HIV infection or those with contraindications to the study interventions may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to improved long-term control of HIV-1 without the need for continuous ART.
How similar studies have performed: Other studies involving broadly neutralizing antibodies have shown promise, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bobigny and 16 other locations
- 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)
- Hôpital Hôtel - Dieu — Paris, France (Recruiting)
- Hôpital Hôtel Dieu - Service d'immunologie clinique — Paris, France (Not_yet_recruiting)
- Hôpital Pitié-Salpêtrière - SMIT — Paris, France (Recruiting)
- Hôpital Lariboisière - Service de médecine interne A — Paris, France (Recruiting)
- Hôpital Saint- Louis - SMIT — Paris, France (Recruiting)
- Hôpital Saint-Antoine - SMIT — Paris, France (Recruiting)
- Hôpital Necker - SMIT — Paris, France (Recruiting)
- Hôpital Bichat - Claude Bernard - SMIT — Paris, France (Recruiting)
- Hôpital Tenon - SMIT — Paris, France (Recruiting)
- Centre médico chirurgical Foch - Suresnes — Suresnes, France (Recruiting)
- CHI Villeneuve-Saint-Georges - SMIT — Villeneuve-Saint-Georges, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.