Status:
COMPLETED
Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors
Lead Sponsor:
IrsiCaixa
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a pilot, proof of concept, open-label clinical trial, to assess the extend of persistent viral reservoir and the level of immune activation in patients receiving suppressive treatment with pro...
Detailed Description
AIDS continues to be a major global health priority. Although important progress has been achieved in preventing new HIV infections and in lowering the annual number of AIDS-related deaths, the number...
Eligibility Criteria
Inclusion
- HIV-1 infected adults (≥18 years old).
- Absence of prior virological failure with protease inhibitors (PIs).
- No mono or dual protease inhibitor therapy previous to HAART initiation.
- Patients had to be on monotherapy with ritonavir-boosted lopinavir (LPV/r 400/100 mg every 12 hours) or darunavir (DRV/r 800/100 mg every 24 hours) for ≥ 12 months. Switching from standard HAART to protease inhibitor monotherapy had to happen with undetectable plasma viremia.
- Complete virological suppression (\<50 copies/mL) for ≥12 months, including at least 2 times during the last year.
- CD4 cell count ≥500 cells/µL.
- Availability (if possible, not mandatory) of a genotype prior to the start of HAART, with absence of any major drug-related mutations.
- Voluntary written informed consent.
Exclusion
- Lactating, pregnancy, or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
- Presence of any polymorphism or mutation associated to raltegravir resistance at baseline (prior to first HAART).
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01480713
Start Date
May 1 2012
End Date
May 1 2014
Last Update
May 7 2024
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916