Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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 protease inhibitors.

40 Chronically HIV-1 infected subjects, receiving monotherapy with ritonavir-boosted lopinavir or darunavir for at least 12 months with plasma viremia below 50 copies HIV RNA per ml, and CD4 T-cell counts greater than 500 cells/mm3 will be included.

The total duration of the study will be 48 weeks: 12 weeks for patients' inclusion, 24 weeks of follow-up once the last patient is included, and 12 weeks for data analysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IrsiCaixa
• Treatments: HIV Protease Inhibitors; Protease Inhibitors; Raltegravir Potassium

Criteria

Inclusion Criteria:

1. HIV-1 infected adults (≥18 years old).

2. Absence of prior virological failure with protease inhibitors (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 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.

5. Complete virological suppression (<50 copies/mL) for ≥12 months, including at least 2 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 major drug-related mutations.

8. Voluntary written informed consent.

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 raltegravir resistance at baseline (prior to first HAART).