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

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00469170
First received: May 3, 2007
Last updated: November 10, 2010
Last verified: November 2010
  Purpose
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.

Condition Intervention Phase
HIV Infections Device: intravaginal ring Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 220
Study Start Date: March 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469170

Locations
South Africa
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
South African Medical Research Council
Durban, KwaZulu Natal, South Africa, 4067
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, South Africa, 7975
Tanzania
Kilimanjaro Reproductive Health Program
Moshi, Tanzania
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Dr. Annalene Nel IPM
  More Information

Responsible Party: Annalene Nel, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00469170     History of Changes
Other Study ID Numbers: IPM 011
Study First Received: May 3, 2007
Last Updated: November 10, 2010

Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1
HIV seronegativity

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2017