A randomized trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in Serodiscordant couples
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- HIV infection in partners
研究概览
简要总结
HPTN 052 is a Phase III, two-arm, randomized, controlled, multi-center trial. The purpose of this study is to determine whether antiretroviral therapy (ART) can prevent the sexual transmission of HIV-1 in HIV-1 serodiscordant couples. This trial consists of a run-in period, which has been completed, and a full study. The target sample size for the full study is approximately 1,750 couples including 82 couples (globally) that enrolled in the run-in period. The enrollment target at NARI site is 200 and at YRG care is 250. The duration of the full study will be approximately 78 months total. Accrual into the study will require approximately 18 months, and all couples will be followed until the last couple enrolled completes their 60-month follow-up visit. The enrollment at NARI sites started in 01 July 2005 and YRG care started in 10 November 2005. Total Enrollments globally as of August 14, 2009 are 1242. Serodiscordant couples in which the HIV-infected index participant is ART-naïve and has a CD4+ cell count of 350-550 cells/mm3 are randomized to receive either immediate ART therapy plus HIV primary care or HIV primary care without initiation of ART until the index participant has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm3, or develops an AIDS-defining illness. The primary objective of this study is to compare rates of HIV infection among partners of HIV-infected index participants in the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Couples are defined as sexual partners same or opposite sex who are married have been living together or consider each other a primary partner.
- •They must have been together for a minimum of three months and at the time of study enrollment expect to maintain their relationship for the duration of the study.
- •Index Case: -Positive HIV serology obtained within 60 days prior to enrollment -Has a sexual partner (as defined above) who is not infected with HIV (documented by negative HIV serology) and who is willing to participate in the study.
- •Plans to maintain a sexual relationship with the person who is enrolled in the study with them.
- •Reports having sex (vaginal or anal) with partner at least 3 times in the last 3 months.
- •If pregnant or breastfeeding during screening or at the time of enrollment, willing to be randomized to either arm of the study.
- •The following conditions must be met for laboratory parameters within 60 days prior to enrollment: CD4+ cell count of 350-550 cells/mm3 Hemoglobin > 7.5 g/dL Platelet count > 50,000/µL.
- •AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 x ULN Total bilirubin < 2.5 x ULN Calculated creatinine clearance > 60 mL/min (use the Cockcroft and Gault method to calculate) Absolute neutrophil count > 750 mm3 or 0.750 x 109/L Partner -Negative HIV serology within 14 days prior to enrollment.
- •Has a sexual partner infected with HIV who is willing to participate in the study.
- •Both Index Case and Partner: -Men and women age > 18 years.
- •Willing to disclose HIV test results to partner.
- •Not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area.
排除标准
- •Index Case:-Current or previous AIDS-defining illness (as defined in Appendix III).
- •Current or previous use of any ART drugs -Documented or suspected acute hepatitis within 30 days prior to enrollment, irrespective of AST (SGOT) and ALT (SGPT) values.-Acute therapy for serious medical illnesses, chronic, acute, or recurrent infections in the opinion of the site investigator-Radiation therapy or systemic chemotherapy, any immunomodulator or other investigational therapy, Active drug or alcohol use or dependence, Allergy/sensitivity to any study drugs.Both Index Case and Partner:-Reports a history of injection drug use within the last five years.-Previous and/or current participant in an HIV vaccine study.-Any condition that, in the opinion of the study staff, would make participation in the study unsafe-Incarceration in a correctional facility.
结局指标
主要结局
HIV infection in partners
时间窗: Throughout study
次要结局
- Determine, characterize, and compare the rates of AIDS-defining illnesses, sexually transmitted diseases, opportunistic infections, and immune reconstitution syndromes, with regard to outcomes and survival as observed in different geographic settings and by antiretroviral treatment strategies.(Throughout study)