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HVTN 704/HPTN 085 (The AMP Study)

Status
Ongoing
Phase
IIb
Principal Investigator(s)
Lawrence Corey, Myron Cohen
Objective

This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North and South America.

The study also looks at the safety of these antibody infusions and it looks over time at how much antibody is in the blood of study participants receiving different amounts or doses of the antibody.

Prevention Option(s)
Antibody Related Research
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Participants will receive an intravenous (IV) infusion of 10 mg/kg of VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Products
VRC01
ARMs
Experimental
Description
Participants will receive an IV infusion of 30 mg/kg of VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Products
VRC01
ARMs
Experimental
Description
Participants will receive an IV infusion of placebo for VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
ARMs
Placebo Comparator
Trial Sponsors
NIAID
March 2016
October 2020
Enrollment
2 700
18
Years
50
Years
Population
Men
MSM
Sites

Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia
United States of America

Ponce de Leon

Atlanta, Georgia
United States of America

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro
Brazil

Brigham and Women's Hospital CRS

Boston, Massachusetts
United States of America

Fenway Health (FH) CRS

Boston, Massachusetts
United States of America

Chapel Hill CRS

Chapel Hill, North Carolina
United States of America

Bronx Prevention Center

Bronx, New York
United States of America

Harlem Prevention Center

New York, NY
United States of America

Columbia P&S CRS

New York, NY
United States of America

UCLA Vine Street Clinic

Los Angeles, California
United States of America

New Jersey Medical School Clinical Research Center CRS

Newark, New Jersey
United States of America

Alabama Vaccine CRS

Birmingham, Alabama
United States of America

Case Western Reserve University/University Hospitals Case Medical Center

Clevelan, Ohio
United States of America

Penn Prevention CRS

Philadelphia, Pennsylvania
United States of America

Bridge HIV CRS

San Francisco, California
United States of America

George Washington University CRS

Washington, District of Columbia
United States of America

Barranco CRS

Lima
Peru

San Miguel Clinical Research Site

Lima
Peru

Via Libre

Lima
Peru

Rochester Victory Alliance

Rochester, New York
United States of America

Vanderbilt Vaccine CRS

Nashville, Tennessee
United States of America

Asociación Civil Selva Amazónica (ACSA)

Iquitos
Peru

Site(s) - Switzerland

Switzerland