PER-066-14招募中未知
HIV TESTING AND TREATMENT TO PREVENT ONWARD HIV TRANSMISSIONAMONG MSM AND TRANSGENDER WOMEN IN LIMA, PER
Centro de Investigacion del Cancer Fred Hutchinson, Estados Unidos,0 个研究点目标入组 2,138 人开始时间: 2015年3月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 2,138
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
- •In Step 1, potential participants must be MSM and transgender women , have sex with men,
- •HIV status, at high-risk for HIV acquisition. Each potential participant must have the ability and
- •willingness to provide informed consent for study participation, including being tested for HIV-1.
- •If HIV infection is not diagnosed, he must be willing to be enrolled in Step 2, and if diagnosed
- •with acute or recent HIV infection be willing to consider participation in Step 3. In particular, if
- •they are HIV seronegative on antibodies analysis, but with evidence of acute infection (HIV-1
- •RNA-positive confirmed by HIV antigen analysis), they should be willing to be re-contacted for
- •further HIV testing and linkage to care.
- •In Step 2, volunteers who were found to have no HIV infection from Step 1 will be re-tested at
- •variable times for incident HIV-1. Roughly, we anticipate testing 800 MSM and transgender
- •women per month and follow-up until July 2015.
- •In Step 3, men with acute or recent HIV-1 infection detected at Step 1 or Step 2; or individuals
- •who have been diagnosed with HIV in any health clinic or laboratory authorized by the Ministry
- •of Health, and that have had a documented negative result in the past three months with no
- •prior ART exposure, with normal hematological, renal and liver function, will be enrolled in a
- •randomized clinical trial for immediate vs. deferred ART, unless ART initiation criteria are met
排除标准
- •1. Any medical, psychological/psychiatric, occupational, or other condition that, in the
- •judgment of the investigator, would interfere with, or serve as a contraindication to,
- •protocol adherence, assessment of safety, or a participant’s ability to give informed
- •2. Seeking HIV test behavior for routine reasons.
- •3. Use of estrogens (or its derivatives) or anti-androgens, administered orally or intramuscularly,
- •during the past three months.
- •Any medical, psychological/psychiatric, occupational, or other condition that, in the judgment of
- •the investigator, would interfere with, or serve as a contraindication to, protocol adherence,
- •assessment of safety, or a participant’s ability to give informed consent;
- •1. Presentation with WHO clinical stage 3 or 4 irrespective of CD4 count.
- •2. Estimated creatinine clearance below 70 mL per minute
- •3. Use within 21 days prior to study entry of drugs that are highly dependent on CYP3A for
- •clearance and for which elevated plasma concentrations are associated with lifethreatening
- •adverse events or drugs that strongly induce CYP3A and lead to lower
- •exposure of one or more components and loss of efficacy of STRIBILD and possible
- •resistance: alfuzosin, astemizole cisapride, ergot aklaloids and derivatives, flecainide,
- •St. John’s wort, lovastatin, simvastatin, triazolam, oral midazolam, pimozide,
- •propafenone, rifampin, simvastatin, sildenafil terfenadine, and fluticasone-containing
- •antigen) confirmed by a second virological test obtained from a separate determination.
- •Test and Treat Early HIV among MSM and Transgender Women in Lima, Peru
- •Version 2.0 Page 36 of 85
- •15 October 2014
- •compounds.. Check the most recent co-formulated
- •elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STRIBILD®) or coformulated
- •emtricitabine/tenofovir DF/efavirenz package inserts for other exclusionary
- •medications.
- •4. Prior receipt of investigational anti-HIV vaccine.
- •5. Ongoing therapy with any of the following:
- •a. Systemic corticosteroids. Short course less than or equal to 21 days of
- •corticosteroids is allowed;
- •b. Systemic chemotherapeutic agents;
- •c. Nephrotoxic systemic agents, including aminoglycosides, amphotericin B,
- •cidofovir, cisplatin, foscarnet, pentamidine;
- •d. Immunomodulatory treatments including Interleukin-2;
- •e. Investigational agents;
- •6. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their
- •formulations;
- •7. Active drug or alcohol use or dependence that, in the opinion of the site investigator,
- •would interfere with adherence to study requirements;
- •8. Serious medical or psychiatric illness that, in the opinion of the site investigator, would
- •interfere with the ability to adhere to study requirements;
- •9. Chronic (HBsAg positive, anti-HBc positive, Ig M anti-HBc negative, and anti-HBs
- •negative) or acute (HBsAg positive, anti-HBc positive, Ig M anti-HBc positive, and anti-
- •HBs negative) hepatitis B infection.
- •10. Use of estrogens (or its derivatives) or anti-androgens, administered orally or intramuscularly,
- •during the past three months.
研究者
相似试验
未知
不适用
HIV TESTING AND TREATMENT TO PREVENT ONWARD HIV TRANSMISSION AMONG FOR MEN WHO HAVE SEX WITH MEN AND TRANSGENDER WOMEN IN LIMA, PERPER-095-12Centro de Investigacion del Cancer Fred Hutchinson, Estados Unidos,
已完成
不适用
Prevention of late presentation of an HIV infectioHIV prevalentieHIV prevalenceNL-OMON22242Prof.dr. A. Verbon, Dr. TEMS de Vries-Sluijs, Dhr. G.P.M. Luiken; Erasmus MC, RotterdamProf.dr. J.M. Prins; AMC, AmterdamDr. J.G. den Hollander; Maasstad zh, Rotterdam4,500
已完成
不适用
Prevention of late presentation of an HIV infectioAIDSHIV10047438NL-OMON40685Erasmus MC, Universitair Medisch Centrum Rotterdam4,000
招募中
不适用
Sisters Antiretroviral therapy Programme for Prevention of HIV ¿ an Integrated Response (SAPPH-IRe)PACTR201312000722390Centre for Sexual Health and HIV/AIDS Research Zimbabwe2,800
已完成
不适用
CHEMOPROPHYLAXIS FOR THE PREVENTION OF HIV IN ME-Z21 Asymptomatic human immunodeficiency virus [HIV] infection statusAsymptomatic human immunodeficiency virus [HIV] infection statusZ21PER-072-06INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS, INSTITUTOS J. DAVID GLADSTONE, FAMILY HEALTH INTERNATIONAL - FHI 360°,2,339