A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
Primary Purpose
HIV Infections
Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
intravaginal ring
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV-1, HIV seronegativity
Eligibility 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
Sites / Locations
- Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
- South African Medical Research Council
- Desmond Tutu HIV Foundation, Masiphumelele
- Kilimanjaro Reproductive Health Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
vaginal ring first 12 weeks & observational safety last 12 weeks
observational safety first 12 weeks & vaginal ring last 12 weeks
Outcomes
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00469170
First Posted
May 3, 2007
Last Updated
November 10, 2010
Sponsor
International Partnership for Microbicides, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00469170
Brief Title
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
Official Title
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
International Partnership for Microbicides, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
vaginal ring first 12 weeks & observational safety last 12 weeks
Arm Title
B
Arm Type
Experimental
Arm Description
observational safety first 12 weeks & vaginal ring last 12 weeks
Intervention Type
Device
Intervention Name(s)
intravaginal ring
Intervention Description
silicone elastomer intravaginal ring containing no drug product
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Annalene Nel
Organizational Affiliation
IPM
Official's Role
Study Director
Facility Information:
Facility Name
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
City
Yeoville
State/Province
Johannesburg
Country
South Africa
Facility Name
South African Medical Research Council
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4067
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation, Masiphumelele
City
Cape Town
ZIP/Postal Code
7975
Country
South Africa
Facility Name
Kilimanjaro Reproductive Health Program
City
Moshi
Country
Tanzania
12. IPD Sharing Statement
Learn more about this trial
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
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