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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469170
• Other study ID #: IPM 011
• Status: Completed
• Phase: Phase 0
• First received: May 3, 2007
• Last updated: November 10, 2010
• Start date: March 2007
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilKenya: Ministry of HealthTanzania: Food & Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Device:
• intravaginal ring
silicone elastomer intravaginal ring containing no drug product

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Countries where clinical trial is conducted

South Africa,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	No
Primary	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		3 months	No