Infección por VIH-1 MedDRA version: 9 Level: LLT Classification code 10008922 Term: Chronic infection with HIV
Conditions
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected adults (>= 18 years old). 2. No previous antiretroviral therapy for more than 2 weeks. 3. HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months. 4. CCR5-tropism comfirmed at screening. 5. Voluntary written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or fertile women willing to be pregnant. 2. Active substance abuse or major psychiatric disease. 3. Presence of NRTI mutations in the screening genotype.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efecto de la intensificación con maraviroc en el cambio a semana 48 del pendiente de caída del DNA viral integrado y no integrado (en PBMCs).;Secondary Objective: Efecto de la intensificación con maraviroc en: - la posible caída de la replicación del VIH-1 residual (con método de determinación de carga viral ultrasensible). - la frecuencia de blips durante el estudio. - la carga viral 50 copies/mL, preceded and followed by determinations <50 copies/mL in previous and posterior controls). - HIV-1 RNA below 50 copies/mL at 48 weeks. - Change in the lymphocyte activation marker HLADR+CD38+ from baseline to week 48. | — |
Countries
Spain
Outcome results
None listed