Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 889
- 试验地点
- 2
- 主要终点
- Change in HIV status compared between arms (tenofovir vs placebo)
研究概览
简要总结
This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.
详细描述
Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal microbicide, in sexually active women at risk for human immunodeficiency virus (HIV) infection in South Africa.
Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir gel with a placebo gel.
Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa
Study Size: 900 women
Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years (inclusive)
- •Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
- •Able and willing to provide adequate locator information for study retention purposes.
- •Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.
- •HIV negative on testing performed by study staff within 30 days of enrolment.
- •Have a negative pregnancy test which was performed by study staff within 21 days of enrolment
- •Agree to use a non-barrier form of contraceptive
- •Agree to adhere to study visits and procedures
排除标准
- •History of adverse reaction to latex.
- •Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):
- •To travel away from the study site for more than 30 consecutive days.
- •To relocate away from the study site.
- •To become pregnant
- •To enrol in any other study of an investigational product or behaviour modification related to HIV prevention.
- •Has a creatinine clearance <50ml/min, as estimated using the method of Cockcroft and Gault(33).
- •Has active Hepatitis B infection (since January 2009)
- •Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
- •Has in the past year participated in any research related to any vaginally applied product/s.
- •Has current STI symptoms and/or other reproductive tract infection requiring treatment, as assessed by study staff. Otherwise eligible participants diagnosed during screening with infection(s) requiring treatment may be enrolled provided that treatment has commenced.
- •Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
研究组 & 干预措施
1
Tenofovir gel (a reverse transcriptase inhibitor)
干预措施: Tenofovir gel (Drug)
2
Universal HEC placebo
干预措施: Placebo (Universal HEC placebo) (Drug)
结局指标
主要结局
Change in HIV status compared between arms (tenofovir vs placebo)
时间窗: Baseline and monthly HIV testing for the duration of the study, an expected average of 18 months
The effectiveness of tenofovir against HIV infection will be measured by comparing the incidence of HIV in the tenofovir arm with that in the placebo arm
次要结局
- To assess the impact of tenofovir gel on viral load(measured at the first visit post HIV infection, and again 3 months later)
- Change in incidence rate of deep epithelial disruption compared between arms(Baseline and monthly assessments for the duration of the study, an expected average of 18 months)
- To assess tenofovir resistance in HIV seroconvertors in the trial(performed at the post-seroconversion visit)
- To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes(Assessed at baseline and monthly for the duration of the study, an expected average of 18 months)
- To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance(Assessed at post study visit)
- Impact of tenofovir gel on other sexually transmitted infections(Change from baseline to study exit)
研究者
Dr Salim S Abdool Karim
Principal Investigator
Centre for the AIDS Programme of Research in South Africa