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

NCT00469170 | Completed Early Phase 1 DMC

• 1 other identifier: IPM 011
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 4

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.

Conditions

HIV Infections

Keywords

HIV-1; HIV seronegativity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

A

EXPERIMENTAL

vaginal ring first 12 weeks \& observational safety last 12 weeks

Device: intravaginal ring

B

EXPERIMENTAL

observational safety first 12 weeks \& vaginal ring last 12 weeks

Device: intravaginal ring

Interventions

intravaginal ring DEVICE

silicone elastomer intravaginal ring containing no drug product

A; B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (4)

Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic

Yeoville, Johannesburg, South Africa

Location

South African Medical Research Council

Durban, KwaZulu-Natal, 4067, South Africa

Location

Desmond Tutu HIV Foundation, Masiphumelele

Cape Town, 7975, South Africa

Location

Kilimanjaro Reproductive Health Program

Moshi, Tanzania

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Dr. Annalene Nel

  Beijing Immupeutics Medicine Technology Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 15, 2010

Record last verified: 2010-11

Locations

TA (1); ZA (3)