Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant human monoclonal antibody (bNAbs): 1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of bNAbs (3BNC117LS \& 10-1074LS) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria.
Placebo: 1. Initiation of combination ART (1 integrase inhibitor + 2 nucleoside analogue reverse transcriptase inhibitors) with additional dual intravenous infusions of placebo (saline solution) between Day 7 and Day 10. 2. Analytical treatment interruption (ATI), 52 weeks later, if good immunologic and virologic conditions. 3. During ATI, plasma HIV-1 RNA and CD4 monitoring, for a maximum of 48 weeks. 4. ART resumption, if participant encounters at least one ART resumption criteria.
Study summary
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.
Eligibility
Primary outcome measure(s)
- Proportion of participants with plasma HIV-1 RNA below 400 cp/mL 24 weeks following ATI (W24 ATI), in the confirmed absence of ART. — at Week 24 of antiretroviral treatment interruption period (ATI)
These participants will be considered as post-treatment controllers.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More ANRS, Emerging Infectious Diseases trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05300035 on ClinicalTrials.gov ↗ ← All trials in France