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Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT03239483

Public ClinicalTrials.gov record NCT03239483. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 8:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Study identification

NCT ID
NCT03239483
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
28 participants

Conditions and interventions

Conditions

Interventions

  • Dapivirine gel Drug
  • Placebo gel Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 25, 2017
Primary completion
Sep 19, 2018
Completion
Sep 19, 2018
Last update posted
Oct 18, 2021

2017 – 2018

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Alabama CRS Birmingham Alabama 35294
University of Pittsburgh CRS Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03239483, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 18, 2021 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03239483 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →