EUCTR2014-001348-39-ES
Active, not recruiting
Not Applicable
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 sitesDecember 10, 2014
ConditionsHIV-1 infectionMedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1 infection
- Sponsor
- Fundación pública andaluza para la gestión de la investigación en salud de Sevilla (FISEVI)
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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