EUCTR2014-001348-39-ES进行中（未招募）不适用
A Phase II, randomized clinical trial to assess the impact of antiretroviral therapy over viral load in seminal fluid in antiretroviral-naive HIV-positive patients - SEM-TAR
Fundación pública andaluza para la gestión de la investigación en salud de Sevilla (FISEVI)0 个研究点开始时间: 2014年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male with HIV-1 infection
- •2. 18 Years and older
- •3. Antiretroviral-naïve
- •4. Plasmatic viral load plasma HIV-1 viral load: RNA ?1.000 y <100.000 copies/mL of plasma
- •5. CD4 count ?200/?l
- •6. No genotyping resistance for studies drugs
- •7. Signed informed consent form (ICF) executed prior to protocol screening assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence or history of genotyping resistance for studies drugs
- •2. Oportunistic infections or malignancy disease
- •3. Symthoms of sexually transmitted disease
- •4. Co-infection with HBV or HIV (positive test for HBsAg or anti-HIV Ab);
- •5. Liver cirrhosis Child-Pugh score B or C .
- •6. Laboratory results upper limit of the normal range grade 3 or 4 ( AIDS Clinical Trials Group)
- •7. Serum estimated Glomerular Filtration Rate (eGFR) <70 ml/min.
- •8. No treatment adherence
- •9. Unable to commit with the study visits
- •10. Withdrawal of Signed informed consent form (ICF)
研究者
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