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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.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004464-30-ES
Enrollment
Unknown
Registered
2011-10-05
Start date
2011-11-22
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

HIV-1 infection MedDRA version: 14.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Isentress Product Name: Isentress Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RALTEGRAVIR CAS Number: 518048-05-0 Concentration unit: mg milligram(s) Concentration type: e

Sponsors

Institut de Recerca e la SIDA - IrsiCaixa-
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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). ? 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. ? 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. ? Effect of RAL intensification on the frequency of blips during the study. ? Changes in soluble CD14—

Secondary

MeasureTime frame
Secondary end point(s): ? The slope of decay of integrated and unintegrated viral DNA. ? 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. ? Effect of RAL intensification on the frequency of blips during the study. ? Changes in soluble CD14;Timepoint(s) of evaluation of this end point: From baseline to 24 weeks—

Countries

Spain

Contacts

Public ContactCRA

FLS Research Support

jtoro@flsida.org93 497 84 14

Outcome results

None listed

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