Clinical Trial


Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women


Brief description

This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.

Detailed Description

This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in preventing HIV-1 infection in healthy women at high risk of HIV infection. Participants will be enrolled from a cohort of heterosexual women in sub-Saharan Africa. An equal number of study participants will be randomized to receive VRC01 mAb by IV infusion at a dose of 10 mg/kg or 30 mg/kg every 8 weeks, or to receive control infusions every 8 weeks. All participants will receive the VRC01 antibody or placebo by intravenous infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. For 3 days following each infusion, participants will be asked to record and report any symptoms to study researchers. In addition to the infusion visits, participants will attend study visits at Weeks 4, 8 + 5 days, 12, 20, 28, 36, 44, 52, 60, 68, 76, 80, 84, 88, and 92. All study visits will include blood collection and HIV testing and counseling. Select study visits will include a medical history review, physical exam, urine collection, pregnancy testing for participants capable of becoming pregnant, risk reduction counseling, and an interview/questionnaire.

Keywords

  •   HIV Infections

Sponsored By

National Institute of Allergy and Infectious Diseases (NIAID)

Unique Study ID

NCT02568215

Investigators and Research Sites Near You - Found( 3 )

No Investigator Listed

University of Pennsylvania
Gaborone, Botswana
Distance from Current Trial is 0 miles

No Investigator Listed

London School of Hygiene and Tropical Medicine
Gaborone, Botswana
Distance from Current Trial is 0 miles

No Investigator Listed

COVID-19 Prevention Network
Gaborone, Botswana
Distance from Current Trial is 0 miles
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