IMPACTO DE LA INTENSIFICACIÓN CON RALTEGRAVIR EN LA LATENCIA VIRAL DE VIH-1 EN PACIENTES CON SUPRESIÓN VIRAL COMPLETA (IMPACT OF RALTEGRAVIR INTENSIFICATION ON HIV-1 VIRAL LATENCY IN PATIENTS WITH PREVIOUS COMPLETE VIRAL SUPPRESSION). - INTEGRA
- Conditions
- Pacientes con infección de VIH-1 (Patients with HIV-1 infection).MedDRA version: 9.1Level: LLTClassification code 10000807Term: Acute HIV infection
- Registration Number
- EUCTR2007-003801-28-ES
- Lead Sponsor
- Fundació de Lluita contra la SIDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
1.HIV-1 infected adults (³18 years old).
2.Absence of prior virological failure.
3.No mono or dual NRTI therapy previous to HAART initiation.
4.Complete virological suppression (<50 copies/mL) for ³ 12 months, including at least 3 times during the last year.
5.Patients on their first HAART regimen including a PI or an NNRTI and at least two nucleos/tide inhibitors. Patients may have changed their HAART due to intolerance or toxicity but not because of treatment failure. VL must have been suppressed below 50 copies/mL during the change.
6.CD4 cell count =400 cells/µL.
7.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) no
F.1.3.1 Number of subjects for this age range
1.Pregnancy, or fertile women willing to be pregnant.
2.Active substance abuse or major psychiatric disease.
3.Presence of drug-related mutations or any polymorphism or mutation associated to RAL resistance prior to first HAART (only if genotype is available).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method