Pacientes con infección de VIH-1 (Patients with HIV-1 infection). MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection
Conditions
Interventions
Product Name: raltegravir
Pharmaceutical Form: Tablet
Current Sponsor code: raltegravir
Other descriptive name: MK-0518
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Fundació de Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (=65 years) no 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 drug-related mutations or any polymorphism or mutation associated to RAL resistance prior to first HAART (only if genotype is available).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs (peripheral blood mononuclear cells).;Primary end point(s): Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs.;Secondary Objective: · Decay of residual HIV-1 replication under RAL intensification (an ultrasensitive RT-PCR assay with a lower limit of quantification of 3 copies/ml is going to be used) · Effect of RAL intensification on the frequency of blips during the study (>50 copies/mL, preceeded and followed by determinations <50 copies/mL in previous and posterior controls). | — |
Countries
Spain
Outcome results
None listed