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

Primary Purpose

HIV INFECTION

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Darunavir

About this trial

This is an interventional treatment trial for HIV INFECTION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hôpital Saint Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darunavir 400mg/d

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients with therapeutic success, defined as no virological failure

Virological failure is defined as confirmed VL > 50 cp/mL and no change of the strategy

Secondary Outcome Measures

Proportions of patients with virological failure (confirmed VL > 50 cp/ml)

Proportions of patients with VL < 50 cp/ml

Proportions of patients with VL between 20 and 50 cp/ml

Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48

Change from baseline in blood HIV DNA at week 48

Emerging drug resistance if virological failure

Treatment adherence

Change from baseline in blood lipids at week 24 and week 48

Change from baseline in glucose at week 24 and week 48

Treatment Digestive tolerance

Full Information

NCT ID

NCT02384967

First Posted

February 23, 2015

Last Updated

January 23, 2017

Sponsor

ANRS, Emerging Infectious Diseases

1. Study Identification

Unique Protocol Identification Number

NCT02384967

Brief Title

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

Acronym

DARULIGHT

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV INFECTION

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Darunavir 400mg/d

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Darunavir

Other Intervention Name(s)

Prezista

Intervention Description

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 Outcome Measure Information:

Title

Proportion of patients with therapeutic success, defined as no virological failure

Description

Virological failure is defined as confirmed VL > 50 cp/mL and no change of the strategy

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Proportions of patients with virological failure (confirmed VL > 50 cp/ml)

Time Frame

Week 48

Title

Proportions of patients with VL < 50 cp/ml

Time Frame

Week 12, Week 24, Week 36, Week 48

Title

Proportions of patients with VL between 20 and 50 cp/ml

Time Frame

Week 12, Week 24, Week 36, Week 48

Title

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

Title

Change from baseline in blood HIV DNA at week 48

Time Frame

Week 48

Title

Emerging drug resistance if virological failure

Time Frame

Week 48

Title

Treatment adherence

Time Frame

Week 48

Title

Change from baseline in blood lipids at week 24 and week 48

Time Frame

Week 24 and Week 48

Title

Change from baseline in glucose at week 24 and week 48

Time Frame

Week 24 and Week 48

Title

Treatment Digestive tolerance

Time Frame

Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Hôpital Saint Louis

City

Paris

ZIP/Postal Code

75010

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

29905808

Citation

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.

Results Reference

derived

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

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