Clinical trial to determinate viral load in seminal fluid in HIV-positive patients without previous treatment

• Conditions: HIV-1 infection; MedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001348-39-ES
• Lead Sponsor: Fundación pública andaluza para la gestión de la investigación en salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-10
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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
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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified