MedTrace Logo

Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

NCT03239483 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-10-19

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.

Conditions

  • HIV Infections

Interventions

DRUG

Dapivirine gel

Dapivirine gel (0.05%); administered rectally

DRUG

Placebo gel

Universal HEC placebo gel; administered rectally

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ross D. Cranston, MD, FRCP · Fundació Lluita Contra la Sida, Hospital Universitari Germans Trias I Pujol

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2018-09-20
Completion
2018-09-20
FDA Drug
Yes

Countries

  • United States
  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239483 on ClinicalTrials.gov