Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The Antiretroviral Treatment Failure Rate at 12 Months.
研究概览
简要总结
The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In the absence of an effective vaccine, focus has shifted to other prevention strategies such as pre-exposure prophylaxis. Tenofovir, with potent activity against retroviruses [1], was developed for oral use as Viread®, which is widely used for HIV treatment. The efficacy of Viread® has been demonstrated in treatment-experienced and naïve patients [2,3]. In antiretroviral-naive patients, the combination of tenofovir with lamivudine and efavirenz has been classified as a preferred regimen in the Department of Health and Human Services treatment guidelines[4], and has been adopted by the South African Department of health as the first line regimen in treatment-naïve HIV infected patients since April 2010. The durability of antiviral response, favourable resistance profile, once daily dosing, and excellent long term safety profile of tenofovir [5], makes this drug an attractive option in both treatment and prevention regimens and its long half-life [6], made it an ideal choice as the first antiretroviral drug to be formulated as a microbicide gel.
The CAPRISA 004 study conducted in South Africa which tested the effectiveness and safety of 1% tenofovir gel showed that the use of tenofovir in a gel formulation reduced HIV acquisition by 39% overall, and by 54% in women with high gel adherence [7]. There have been concerns raised regarding the use of tenofovir in both PrEP and treatment regimens due to the potential for selection of viral mutations and development of resistance in patients who have become HIV-infected while on PrEP.
There have been no studies conducted to determine whether using tenofovir in pre-exposure prophylaxis affects treatment outcomes in patients who later use tenofovir, which is part of the first line ART of South Africa.
This study aims to determine whether prophylactic exposure to tenofovir gel alters the therapeutic response to a tenofovir containing antiretroviral regimen.
详细描述
Purpose:
To determine whether prophylactic exposure to tenofovir gel alters the therapeutic response to a tenofovir containing antiretroviral regimen
Study design:
Open label, two-arm, randomised controlled trial
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Previously enrolled in the CAPRISA 004 or CAPRISA 008 study - placebo or active arms
- •Able and willing to provide informed consent to be screened for, and to enrol in, the study
- •Able and willing to provide adequate locator information for study retention purposes
- •Confirmed HIV infection in the CAPRISA 004 or 008 trial
- •Agree to adhere to study visits and procedures
排除标准
- •Currently on antiretroviral therapy (including PMTCT prophylaxis)
- •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
Tenofovir, lamivudine and efavirenz
干预措施: Tenofovir, lamivudine and efavirenz (Drug)
Zidovudine, lamivudine and efavirenz
干预措施: Tenofovir, lamivudine and efavirenz (Drug)
结局指标
主要结局
The Antiretroviral Treatment Failure Rate at 12 Months.
时间窗: 12 months post ART intiation or until time of death
Treatment failure is defined as viral load \> 50 copies/ml, antiretroviral regimen changes for treatment failure or death
次要结局
- Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables(From randomisation until either time of termination or time of death)
- Genital Viral Shedding (Viral Load on Tear Flow)(3 years)
- Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation(Measured at 12 months post ART initiation)
- Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations(From randomisation until either time of termination or time of death)
- Cellular and Humoral Immune Responses(3 years)
研究者
Dr Salim S Abdool Karim
Director
Centre for the AIDS Programme of Research in South Africa