Impact of Raltegravir Intensification on HIV-1-infected Subjects with Viral Suppression under Monotherapy with Protease Inhibitors. A 24-week controlled, open-label, pilot clinical trial.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. HIV-1 infected adults (?18 years old).
2. Absence of prior virological failure with PIs.
3. No mono or dual protease inhibitor therapy previous to HAART initiation.
4. Patients had to be on monotherapy with ritonavir-boosted lopinavir (LPV/r 200/50 mg BID) or darunavir (DRV/r 800/100 mg QD) for ? 12 months. Switching from standard HAART to protease inhibitor monotherapy had to happen with undetectable plasma viremia.
5. Complete virological suppression (<50 copies/mL) for ?12 months, including at least 3 times during the last year.
6. CD4 cell count ?500 cells/µL.
7. Availability (if possible, not mandatory) of a genotype prior to the start of HAART, with absence of any drug-related mutations and specifically of any polymorphism or mutation associated to Raltegravir resistance.
8. 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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Lactating, Pregnancy, or fertile women willing to be pregnant.
2. Active substance abuse or major psychiatric disease.
3. Presence of any polymorphism or mutation associated to RAL resistance at baseline (prior to first HAART).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the extend of persistent viral reservoir and the level of immune activation in patients receiving suppressive treatment with protease inhibitors.;Primary end point(s): ? Change over a 24-week period in the detection of HIV-1 episomal DNA (2-LTR circles).<br>? Change over a 24-week period in lymphocyte activation markers in PBMCs.;Timepoint(s) of evaluation of this end point: From baseline to 24 weeks;Secondary Objective: ? To asses the slope of decay of integrated and unintegrated viral DNA.<br>? An ultrasensitive RT-PCR assay with a lower limit of quantification of 3 copies/ml will be used to assess the possible decay of residual HIV-1 replication under RAL intensification.<br>? Effect of RAL intensification on the frequency of blips during the study.<br>? Changes in soluble CD14

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? The slope of decay of integrated and unintegrated viral DNA.<br>? An ultrasensitive RT-PCR assay with a lower limit of quantification of 3 copies/ml will be used to assess the possible decay of residual HIV-1 replication under RAL intensification.<br>? Effect of RAL intensification on the frequency of blips during the study.<br>? Changes in soluble CD14;Timepoint(s) of evaluation of this end point: From baseline to 24 weeks