A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method

November 10, 2010 updated by: International Partnership for Microbicides, Inc.

A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa, 7975
        • Desmond Tutu HIV Foundation, Masiphumelele
    • Johannesburg
      • Yeoville, Johannesburg, South Africa
        • Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4067
        • South African Medical Research Council
  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Reproductive Health Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, age 18-35 years
  • Willing and able to provide written informed consent
  • HIV-uninfected and otherwise healthy
  • Self-reported sexually active
  • On a stable hormonal contraceptive regimen
  • Regular menstrual cycle
  • Willing to refrain from use of vaginal products or objects during the study

Exclusion Criteria:

  • Currently pregnant or last pregnancy within 3 months prior to enrollment
  • Currently breast-feeding
  • Participated in any other research study within 30 days prior to enrollment;
  • Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
  • Presence of abnormal physical finding on the vulva, vaginal walls or cervix
  • History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
  • Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
  • Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
  • Any serious acute, chronic or progressive disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
vaginal ring first 12 weeks & observational safety last 12 weeks
Device: intravaginal ring
silicone elastomer intravaginal ring containing no drug product
Experimental: B
observational safety first 12 weeks & vaginal ring last 12 weeks
Device: intravaginal ring
silicone elastomer intravaginal ring containing no drug product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
Time Frame: 3 months
3 months
The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Partnership for Microbicides, Inc.

Investigators

  • Study Director: Dr. Annalene Nel, IPM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM 011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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