Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults

Summary

Antibodies are natural proteins that the body makes to fight infections. Antibodies can also be manufactured like a drug and infused or injected into the body to prevent or treat a disease. The purpose of this study is to test the safety of and the body's response to an antibody against HIV in healthy, HIV-uninfected adults.

Timeline

Start

2014-08

Primary completion

2016-02

Completion

2016-02

Publications

• Mayer KH, Seaton KE, Huang Y, Grunenberg N, Isaacs A, Allen M, Ledgerwood JE, Frank I, Sobieszczyk ME, Baden LR, Rodriguez B, Van Tieu H, Tomaras GD, Deal A, Goodman D, Bailer RT, Ferrari G, Jensen R, Hural J, Graham BS, Mascola JR, Corey L, Montefiori DC; HVTN 104 Protocol Team; and the NIAID HIV Vaccine Trials Network. Safety, pharmacokinetics, and immunological activities of multiple intravenous or subcutaneous doses of an anti-HIV monoclonal antibody, VRC01, administered to HIV-uninfected adults: Results of a phase 1 randomized trial. PLoS Med. 2017 Nov 14;14(11):e1002435. doi: 10.1371/journal.pmed.1002435. eCollection 2017 Nov.

Drugs

Indications