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

This study is currently recruiting participants.
Verified by International Partnership for Microbicides, Inc., July 2008

Sponsored by: International Partnership for Microbicides, Inc.
Information provided by: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT00469170
  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

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety Study
Official Title:   A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women

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 ]

Estimated Enrollment:   200
Study Start Date:   March 2007
Estimated Primary Completion Date:   January 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
vaginal ring first 12 weeks & observational safety last 12 weeks
Device: intravaginal ring
silicone elastomer intravaginal ring containing no drug product
B: Experimental
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

Contacts
Contact: Karen Douville     301-608-2221     kdouville@ipm-microbicides.org    

Locations
Kenya
International Centre for Reproductive Health     Withdrawn
      Mombasa, Kenya
South Africa
Desmond Tutu HIV Foundation, Masiphumelele     Not yet recruiting
      Cape Town, South Africa, 7975
      Contact: Prof. Linda-Gail Bekker         linda-gail.bekker@hiv-research.org.za    
      Principal Investigator: Dr. Linda-Gail Bekker            
      Sub-Investigator: Dr. Danielle Klemp            
      Sub-Investigator: Dr. Jennifer Pitt            
South Africa, Johannesburg
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic     Completed
      Yeoville, Johannesburg, South Africa
South Africa, KwaZulu Natal
South African Medical Research Council     Recruiting
      Durban, KwaZulu Natal, South Africa, 4067
      Principal Investigator: Dr. Avashri Naidoo            
Tanzania
Kilimanjaro Reproductive Health Program     Recruiting
      Moshi, Tanzania
      Contact: Dr. Saidi Kapiga     255-272-750663     Saidi.Kapiga@lshtm.ac.uk    
      Sub-Investigator: Dr. Sarah Chiduo            
      Principal Investigator: Dr. Gileard Masenga            
      Sub-Investigator: Dr. Saidi Kapiga            

Sponsors and Collaborators
International Partnership for Microbicides, Inc.

Investigators
Study Director:     Dr. Annalene Nel     IPM    
  More Information

Responsible Party:   International Partnership for Microbicides ( Karen Douville, Executive Director for Operations & Planning )
Study ID Numbers:   IPM 011
First Received:   May 3, 2007
Last Updated:   July 10, 2008
ClinicalTrials.gov Identifier:   NCT00469170
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  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on September 05, 2008




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