Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)

Phase 1 Completed 40 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).

Timeline

Start: 2015-08-25
Primary completion: 2016-04-15
Completion: 2016-09-29

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A: VRC01 Followed by Placebo vs Arm B: Placebo Followed by VRC01; p = 0.16; NCT02411539 ↗

paper The median fold-change in the cell-associated HIV-1 RNA/DNA ratio from baseline to week 6 was 1.12 and 0.83 for the VRC01 and placebo arms, respectively, with no significant difference between arms (P = .16). PMID 30364428 ↗

Publications

Riddler SA, Zheng L, Durand CM, Ritz J, Koup RA, Ledgerwood J, Bailer RT, Koletar SL, Eron JJ, Keefer MC, Macatangay BJC, Cyktor JC, Mellors JW; AIDS Clinical Trials Group A5342 Protocol Team. Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis. 2018 Oct 20;5(10):ofy242. doi: 10.1093/ofid/ofy242. eCollection 2018 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VRC01	Monoclonal antibody	40 mg/kg	Intravenous