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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-).

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-).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005473-35-ES
Enrollment
57
Registered
2008-09-25
Start date
2008-11-12
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infección VIH-1 MedDRA version: 9 Level: LLT Classification code 10008919 Term: Chronic HIV infection

Interventions

Trade Name: ISENTRESS 400 mg comprimidos recubiertos Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RALTEGRAVIR POTASIO Other descriptive name: RALTEGRAVIR POTASIO Concentration unit: mg

Sponsors

Fundació Lluita contra la SIDA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =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.Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion. 3.Hepatic toxicity (AST, ALT levels grade > o = 3).

Design outcomes

Primary

MeasureTime frame
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. ?To determine whether a correlation exists between immune activation, apoptotic activity, and immunologic response. ?To assess the antiviral efficacy after intensification with Raltegravir. ?To assess the safety after intensification with Raltegravir.;Primary end point(s): CD4 cell count.—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026