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HVTN 703/HPTN 081 (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 in high-risk, HIV-uninfected women.

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
April 2016
September 2020
Enrollment
1 900
18
Years
50
Years
Population
Women
Sites

Groote Schuur HIV CRS

Cape Town
South Africa

Soweto HVTN CRS

Johannesburg
South Africa

eThekwini CRS

Durban, KwaZulu-Natal
South Africa

CAPRISA Vulindlela Clinical Research Site

Pietermaritzburg, KwaZulu-Natal
South Africa

Gaborone CRS

Gaborone
Botswana

Kisumu CRS

Kenya

Blantyre CRS

Malawi

Malawi CRS

Malawi

Centro de Investigação e Treino em Saúde de Polana Caniço

Maputo
Mozambique

Chatsworth CRS

Chatsworth, KwaZulu-Natal
South Africa

Wits HIV CRS

Johannesburg, Gauteng
South Africa

Mbeya Med. Research Program, Mbeya Referral Hospital CRS

Mbeya
United Republic of Tanzania

Seke South Clinical Research Site

Harare
Zimbabwe

UZ-Parirenyatwa

Harare
Zimbabwe

Spilhaus Clinical Research Site

Harare
Zimbabwe