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An Expanded Safety Study of Dapivirine Gel 4789 in Africa

NCT00917904 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-12-14

No results posted yet for this study

Summary

The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.

Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Healthy

Interventions

DRUG

dapivirine

dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks

DRUG

placebo

dosage form: vaginal gel frequency: once daily duration: 6 weeks

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr Annalene Nel · Beijing Immupeutics Medicine Technology Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

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 NCT00917904 on ClinicalTrials.gov