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Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection

NCT00262106 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9404

Last updated 2012-09-10

No results posted yet for this study

Summary

The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.

Conditions

  • HIV Infections
  • Gonorrhea
  • Chlamydial Infections
  • Genital Herpes

Interventions

DRUG

PRO 2000/5

Gel

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • Department for International Development, United Kingdom

    collaborator OTHER_GOV

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sheena McCormack, MBBS, MSc, FRCP · MRC Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-08-31
Completion
2009-09-30

Countries

  • South Africa
  • Tanzania
  • Uganda
  • Zambia

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00262106 on ClinicalTrials.gov