A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- International Partnership for Microbicides, Inc.
- Enrollment
- 2629
- Locations
- 7
- Primary Endpoint
- Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
Detailed Description
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women." MTN-020 will enroll approximately 3676 sexually active HIVnegative women aged 18-45 years randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a placebo vaginal ring. Rings will be inserted once every 28 days for 12 consecutive months. MTN expects to initiate this study in August 2012.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 through 45 years (inclusive) at screening, verified per site SOPs; within this range, sites may restrict the upper age limit per site SOPs, to target women at high risk of HIV infection
- •Able and willing to provide written informed consent to be screened for and to take part in the study
- •Able and willing to provide adequate locator information, as defined in site SOPs
- •HIV-uninfected based on testing performed by study staff at screening and enrollment (per applicable algorithm in Appendix II)
- •Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
- •Using an effective method of contraception at enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine device (IUD); and sterilization (of participant, as defined in site SOPs)
- •At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation -- Note: Tampons may be used for the duration of the trial.
Exclusion Criteria
- •Per participant report at screening:
- •Intends to become pregnant during study participation
- •Plans to relocate away from the study site during study participation
- •Plans to travel away from the study site for more than 8 consecutive weeks during study participation
- •Is pregnant
- •- Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
- •Currently breastfeeding
- •Diagnosed with urinary tract infection (UTI)
- •- Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 28 days of obtaining informed consent for screening, the participant may be enrolled.
- •Diagnosed with pelvic inflammatory disease, an STI or reproductive tract infection (RTI) requiring treatment per current WHO guidelines
Outcomes
Primary Outcomes
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.
Time Frame: minimum of 12 months and a maximum of 14 months per participant
The primary endpoint is HIV-1 seroconversion as measured by rapid and specialised laboratory testing according to comprehensive HIV testing algorithm. Endpoint confirmation of HIV infection is by Western Blot.
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks).
Time Frame: minimum of 12 months and a maximum of 14 months per participant
Participants with grade 2 adverse events, judged to be related to investigational product, grade 3 and grade 4 adverse events and all serious adverse events. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
Secondary Outcomes
- Adherence to the Dapivirine Vaginal Ring.(12 months per participant)
- Acceptability of the DVR and Placebo Vaginal Ring(12 months per participant)
- Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.(minimum of 12 months and a maximum of 14 months per participant)