HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Number of Participants With HIV Viral Load Suppression in Plasma
研究概览
简要总结
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people.
In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.
详细描述
This is three-step study. Step 1 will screen men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will be conducted for several thousand MSM and transgender women from study opening until July 2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation criteria.) All participants will be followed for 48 weeks after which they will continue ART from other sources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult men who have sex with men, and transgender women
- •Unaware of HIV status at enrollment in follow-up cohort
- •High risk for HIV infection
- •Willing to test for HIV
- •No prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days
- •Willing to provide informed consent
排除标准
- •Prior receipt of investigational anti-HIV vaccine
- •Ongoing therapy with any of the following:
- •Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed
- •Systemic chemotherapeutic agents
- •Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine
- •Immunomodulatory treatments including Interleukin-2
- •Investigational agents
- •Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations
- •Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- •Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements
- •Chronic or acute hepatitis B infection
- •Use of female hormonal products based on estrogen or derivatives
研究组 & 干预措施
Immediate ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
干预措施: Atripla or Stribild (Drug)
Deferred ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
干预措施: Atripla or Stribild (Drug)
结局指标
主要结局
Number of Participants With HIV Viral Load Suppression in Plasma
时间窗: Baseline, Week 12, Week 24, Week 36, and Week 48
To quantify HIV viral load suppression (\<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was \<1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was \<1000 copies/mL etc.
Number of Participants With HIV Viral Load Suppression in Semen
时间窗: Baseline, Week 12, and Week 24
To quantify HIV viral load suppression (\<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks
次要结局
- Adherence to ART Regimen (Percentage of Pills Taken)(48 weeks)
- Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection(HIV diagnosis visit)
- Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters(HIV diagnosis visit)
- Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care(within 3 months of diagnosis of acute HIV infection)
- Partner Tracing(within 3 months of diagnosis)
- Number of Participants Retained in Care(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Adherence to Viral Load (VL) Procedure(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Adherence to CD4 Procedure(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Adherence to Questionnaires(Baseline, Week 12, Week 24, Week 36, and Week 48)
研究者
Ann C Duerr
Professor (Member)
Fred Hutchinson Cancer Center