PER-055-13已完成未知
RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL TO ASSESS THE IMPACT OF ORAL NALTREXONE ON HIV TREATMENT OUTCOMES AMONG HIV-1 INFECTED MEN WHO HAVE SEX WITH MEN AND TRANSGENDER WOMEN WITH ALCOHOL USE DISORDERS IN LIMA, PER
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 159
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
- 年龄范围
- 18 至 99（—）
- 性别
- Male
入选标准
- •1.Between 18 and 64 years of age
- •2.Confirmed HIV infection, either through detection of HIV antibody or HIV-1 RNA or p24 antigen
- •3.Recent diagnosis of HIV infection in the previous 90 days.
- •4.Biologically male and identifying as MSM or transgender woman in the previous 12 months
- •5.Meet DSM-IV criteria for having an AUD, specifically alcohol dependence or hazardous drinking (based on an AUDIT score ≥8).
- •6.No evidence of acute alcohol withdrawal syndrome (based in a Clinical Institute Withdrawal Assessment for Alcohol -- CIWA-Ar -- scale)
- •7.No participation in medication-assisted therapy and/or a psychotherapy research trial for treatment of AUD in the previous 30 days.
- •8.Willing and able to provide informed consent.
- •9.No plans to have surgery within the next 6 months
- •10.No plans to travel extensively for the year.
- •11.Able to provide contact information, including:
- •One or more phone numbers (cell and/or home) and/or a street address of residence for themselves; and
- •Personal contact information (ideally from two or more people) who would know their whereabouts during the study period.
- •12.Adequate hepatic function (hepatic transaminases (ALT and AST) ≤ 3 x upper limit of normal within 90 days before enrollment);
- •13.Adequate renal function (creatinine clearance ≥ 50 ml/min estimated by the Cockcroft Creatinine Clearance Formula AND serum creatinine level within normal limits) within 90 days before enrollment;
- •14.Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm3; platelets within normal limits, and hemoglobin ≥ 10 g/dL within 28 days before enrollment).
- •15.No previous or current treatment with ART.
- •16.Was not prescribed PrEP (ART).
排除标准
- •1.Active clinically significant medical problems, including an active opportunistic infection (e.g., unexplained fever, weight loss, chronic cough) or having an emergent need for hospitalization at the time of screening (e.g. suicidal or homicidal ideation, unstable angina pectoris, etc).
- •2.Active hepatitis B infection determined by the following hepatitis serological results: total hepatitis B core antibody (anti-HBc) positive, hepatitis B surface antibody (anti-HBs) negative and hepatitis B surface antigen positive at the screening visit.
- •3.Childs-Pugh Class C Cirrhosis
- •4.Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioids.
- •5.Positive urine test for opioids.
- •6.Concomitant participation in a clinical trial or cohort study other than sub-studies of this protocol
- •7.Incarceration or institutionalization or charges anticipating arrest.
- •8.At enrollment, having 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.
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