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

NCT ID: NCT02384967

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-10-31

Brief 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.

Detailed 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.

Conditions

HIV INFECTION

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Darunavir 400mg/d

Tri-therapy containing Darunavir at dose of 400 mg/d.

Group Type: EXPERIMENTAL

Darunavir

Intervention Type: DRUG

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.

Interventions

Darunavir

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.

Intervention Type: DRUG

Other Intervention Names

Prezista

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Saint Louis

Paris, , France

Countries

France

References

Le MP, Chaix ML, Chevret S, Bertrand J, Raffi F, Gallien S, El Abbassi EMB, Katlama C, Delobel P, Yazdanpanah Y, Saillard J, Molina JM, Peytavin G; ANRS 165 DARULIGHT Study Group. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. J Antimicrob Chemother. 2018 Aug 1;73(8):2120-2128. doi: 10.1093/jac/dky193.

Reference Type: DERIVED

PMID: 29905808 (View on PubMed)

Other Identifiers

ANRS 165 DARULIGHT

Identifier Type: -

Identifier Source: org_study_id