Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Darunavir; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• HIV-1 infected adults,

• age ≥ 18 years,

• with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),

• virologically controlled (VL ≤ 50 cp/ml,

• ≥ 1 year,

• at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months,

• virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and

• with no history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),

• no current opportunistic infection,

• renal clearance ≥ 60 mL/min if tenofovir is used,

• transaminases (SGOT, SGPT) plasma levels < 2N,

• hemoglobin > 11 g/dL,

• platelets count > 150 000/mm3,

• negative pregnancy test in women with childbearing potential,

• informed written consent signed by both the investigator and the subject,

• national insurance scheme (article L1121-11 of the French Public Health code),

• no participation to any other clinical trial

Exclusion Criteria:

• HIV-2 infection,

• current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,

• virus genotypically resistant to darunavir and the used NRTIs,

• history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),

• irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,

• current pregnancy,

• current opportunistic infection,

• associated treatment containing one or more drugs interacting with hepatic cytochromes,

• any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.