| Protocol No: | ECCT/16/04/01 | Date of Protocol: | 11-08-2015 |
| Study Title: |
HVTN 703/HPTN 081
A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection
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| Study Objectives: | Primary objective 1: To evaluate the safety and tolerability of VRC01 mAb administered through IV infusion in sub-Saharan African women Primary objective 2: To determine if the VRC01 mAb prevents HIV-1 infection and to estimate the level of efficacy in sub-Saharan African women
Secondary objective 1: To develop a marker(s) of the VRC01 mAb that correlates with the level and antigenic specificity of protection against HIV-1 infection and to provide insight into the mechanistic correlates of protection
Exploratory objective 1: To assess use of FTC/TDF in the study cohort Exploratory objective 2: To assess if prevention efficacy is modified by FTC/TDF use Exploratory objective 3: To understand changes in risk behavior and the potential for risk compensation for all study participants Exploratory objective 4: To measure anti-idiotype antibodies to VRC01 |
| Laymans Summary: | The AMP Study (also known as HVTN 703/HPTN 081) tests an experimental antibody against HIV. AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies that fight HIV to see if they will protect people from becoming HIV infected. The AMP study tests an antibody called VRC01, a manufactured antibody against HIV. This is a new idea for HIV prevention that is related to what has been done in HIV vaccine research. In traditional HIV vaccine studies, people get a vaccine and researchers wait to see if their bodies will make antibodies against HIV in response to the vaccine. In this study, we will skip that step, and give people the antibodies directly. The study will enroll and follow about 1,900 adult women in sub-Saharan Africa who are at risk of HIV-1 infection. To join this study, a woman must be a healthy adult and not infected with HIV. She cannot be pregnant or breastfeeding. |
| Abstract of Study: |
VRC01: human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB in formulation buffer at pH 5.8 in sufficient normal saline (Sodium Chloride for Injection 0.9%, USP) to be administered at a final volume of 150 mL intravenously (IV)
o Control for VRC01: Sodium Chloride for Injection 0.9%, USP administered at a volume of 150 mL IV
o VRC01 or control will be infused every 8 weeks for a total of 10 infusions
o The study products are being provided by the Dale and Betty Bumpers Vaccine Research Center (VRC), NIAID, NIH, DHHS (Bethesda, Maryland, USA)
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