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

HIV Infections Clinical Trial

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Drug Levels of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01) Administered in Multiple Doses Intravenously and Subcutaneously in Different Dosing Schedules to Healthy, HIV-Uninfected Adults

Status Completed

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to evaluate the safety, tolerability, and drug levels of five different schedules for the intravenous (IV) and subcutaneous (SC) administration of a human monoclonal antibody (VRC-HIVMAB060-00-AB [VRC01]) against HIV in healthy, HIV-uninfected adults.

The study will enroll 88 healthy, HIV-uninfected adults aged 18 to 50 years.

This study will enroll participants in 5 groups. Groups 1-3 will enroll simultaneously. Groups 1 and 2 will be randomized together but not blinded, while Group 3 will be randomized separately and will be blinded. With the implementation of Version 2.0, Groups 4 and 5 will be randomized together and will enroll simultaneously. Each group will have a different schedule of clinic visits and receive different doses of VRC01 or placebo for VRC01. Participants will attend 8 months of scheduled clinic visits.

Participants in Group 1 will receive an IV infusion of VRC01 on Days 0, 28, 56, 84, 112, and 140. Participants in Group 2 will receive an IV infusion of VRC01 on Days 0, 56, and 112. Participants in Group 3 will receive an IV infusion of VRC01 or IV placebo for VRC01 on Day 0, followed by SC injections of VRC01 or SC placebo for VRC01 on Days 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, and 154. Participants in Groups 4 and 5 will receive an IV infusion of VRC01 (each group will receive a different dose) on Days 0, 56, and 112.

Participants will remain in the clinic for about an hour after receiving the infusions and injections for observation and monitoring. Participants in Group 3 who have no problems with the first SC injection will have to wait in the clinic for only a half an hour after the rest of the SC injections.

At study entry, participants will give a medical history; undergo a physical exam, blood collection, and urine collection; and receive HIV risk reduction counseling. At follow-up visits, participants will undergo a brief physical exam and blood collection, receive HIV risk reduction counseling, and be asked questions about their health and their experience participating in the study. At all visits, participants who were born female will have a pregnancy test. At select study visits, saliva, rectal, and semen or cervical secretion samples will be collected from participants who consent to collection of these samples. ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT02165267
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: August 2014
• Completion date: February 2016