PILOT STUDY TO ASSESS THE ROLE OF IMMUNE ACTIVATION AND APOPTOSIS AS A MARKER FOR TREATMENT INTENSIFICATION WITH RALTEGRAVIR IN HIV-INFECTED PATIENTS ON ANTIRETROVIRAL THERAPY WITH LONG-TERM VIRAL SUPPRESSION AND UNFAVOURABLE IMMUNOLOGIC RESPONSE (DISCORDANT PATIENTS: V+I-).

Phase 1

• Conditions: Infección VIH-1; MedDRA version: 9Level: LLTClassification code 10008919Term: Chronic HIV infection

• Registration Number: EUCTR2008-005473-35-ES
• Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-25
• Study Completion: 2011-05-18
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1.Patient having a diagnosis of HIV infection, on continuously HAART for at least 2 years, including:
a.2 NRTI/NtRTIs (except ddI+TDF), plus
b.1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or 1 NNRTI (nevirapine or efavirenz)
2.Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) during the last 2 years prior to screening (with at least 4 determinations of viral load during this time period).
3.Good treatment adherence.
4.No presence of other factors which could contribute to CD4+ declines, such as treatment with chemotherapy, treatment with interferon/ribavirin, a ddI+TDF-containing regimen, etc, at least 12 months prior to screening.
5.Patient classified as ?discordant? who showed high level of CD8+HLADR+CD38+ and cell death values at the screening (see reference values in the definition section in page 9: 4.2. AIMS).
6.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

Exclusion Criteria

1.Pregnancy or fertile women willing to be pregnant.
2.Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
3.Hepatic toxicity (AST, ALT levels grade > o = 3).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether the intensification with Raltegravir affect the immune recovery in ?discordant? patients with high level of CD8+HLADR+CD38+.;Secondary Objective: ?To determine immune activation and apoptotic parameters after intensification with Raltegravir in ?discordant? patients showing high level of immune activation at baseline.<br>?To determine whether a correlation exists between immune activation, apoptotic activity, and immunologic response.<br>?To assess the antiviral efficacy after intensification with Raltegravir.<br>?To assess the safety after intensification with Raltegravir.;Primary end point(s): CD4 cell count.