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Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults

HIV Infections Clinical Trial

Official title:
A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the Serum and Mucosa of Healthy, HIV-Uninfected Adult Participants

Clinical Trial Summary

This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.

Clinical Trial Description

This study will evaluate two experimental human monoclonal antibodies (mAbs): VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS). VRC01LS is designed to have a longer half-life than VRC01. The purpose of this study is to evaluate the safety, pharmacokinetics, and antiviral activity of VRC01 and VRC01LS in the serum and mucosa of healthy, HIV-uninfected adults. This study will enroll healthy, HIV-uninfected adults into five groups. At various time points during the study, participants in Groups 1, 2, and 4 will receive intravenous (IV) infusions of VRC01, and participants in Groups 3 and 5 will receive IV infusions of VRC01LS. Participants in Groups 1, 2, and 3 will attend 13 to 14 study visits over about 1 to 1 ½ years; participants in Groups 4 and 5 will attend 7 to 9 study visits over about 6 months to 1 year. At certain time points, study visits will include physical examinations, blood collection, urine collection, and interviews and questionnaires. At other time points, depending on group assignment and gender, visits will also include collection of cervicovaginal secretions, rectal secretions, and semen; and cervical, vaginal, and rectal biopsies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02797171
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date March 1, 2017
Completion date June 5, 2019
View Details
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