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

ANRS, Emerging Infectious Diseases

Status and phase

Completed

Phase 2

Conditions

HIV INFECTION

Treatments

Drug: Darunavir

Study type

Interventional

Funder types

Other

Identifiers

NCT02384967

ANRS 165 DARULIGHT

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.