CTRI/2009/091/000644已完成3 期
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
ational Institute of Health USA0 个研究点目标入组 1,750 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •-Negative HIV serology within 14 days prior to enrollment.
- •-Has a sexual partner infected with HIV 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.
- •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
研究者
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