Overview

This trial is active, not recruiting.

Condition hiv infection
Treatment darunavir
Phase phase 2
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date March 2015
End date December 2016
Trial size 100 participants
Trial identifier NCT02384967, ANRS 165 DARULIGHT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Tri-therapy containing Darunavir at dose of 400 mg/d.
darunavir Prezista
to assess 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.

Primary Outcomes

Measure
Proportion of patients with therapeutic success, defined as no virological failure
time frame: Week 48

Secondary Outcomes

Measure
Proportions of patients with virological failure (confirmed VL > 50 cp/ml)
time frame: Week 48
Proportions of patients with VL < 50 cp/ml
time frame: Week 12, Week 24, Week 36, Week 48
Proportions of patients with VL between 20 and 50 cp/ml
time frame: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48
time frame: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood HIV DNA at week 48
time frame: Week 48
Emerging drug resistance if virological failure
time frame: Week 48
Treatment adherence
time frame: Week 48
Change from baseline in blood lipids at week 24 and week 48
time frame: Week 24 and Week 48
Change from baseline in glucose at week 24 and week 48
time frame: Week 24 and Week 48
Treatment Digestive tolerance
time frame: Week 48

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Description Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d. Secondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL > 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).