HPTN 083

Not Applicable

Recruiting

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-053-16
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 0

Inclusion Criteria

Men who have sex with men and Transgender women ≥ 18 years; Willing to provide informed consent for the study; At high risk for sexually acquiring HIV infection based self-report; In general good health, as evidenced by laboratory values, which must be from specimens obtained within 45 days prior to study enrollment; HIV uninfected, based on HIV test results; No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study; Willing to undergo all required study procedures

Exclusion Criteria

One or more reactive or positive HIV test result; Active or recent use of any illicit intravenous drugs in the last 90 days prior to enrollment; Co-enrollment in any other interventional research study; Past or current participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm); Clinically significant cardiovascular disease; Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, per the discretion of the Investigator; Mild skin conditions may not be exclusionary at the discretion of the Investigator; Has a tattoo or other dermatological condition overlying the buttock region which may interfere with interpretation of injection site reactions; Current or chronic history of liver disease or known hepatic or biliary abnormalities; Coagulopathy which would contraindicate IM injection; Active or planned use of prohibited medications as described in the Investigator’s Brochure; Known or suspected allergy to study product components (active or placebo); Surgically-placed buttock implants, per self-report; Alcohol or substance use that would jeopardize the safety of the participant on study; History of seizure disorder, per self-report

Study & Design

• Study Type: Interventional
• Study Design: Not specified