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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
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
Genders 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
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

No publications provided

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
Health Authority: South Africa: Medicines Control Council
Kenya: Ministry of Health
Tanzania: Food & Drug Administration

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

Additional relevant MeSH terms:
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 14, 2013