Clinical Trials

MainTitle

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

This study has been completed
Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)


Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT02384967

First received: February 23, 2015
Last updated: January 23, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV INFECTION

Drug : Darunavir
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • Proportion of patients with therapeutic success, defined as no virological failure [ Time Frame: Week 48 ]
    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) [ 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 ]

Enrollment: 100
Study Start Date: March 2015
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Darunavir 400mg/d
Tri-therapy containing Darunavir at dose of 400 mg/d.
Drug: 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.

Other Name: Prezista

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02384967

Locations

France
Hôpital Saint Louis
Paris, France, 75010

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
More Information

More Information


Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)  
ClinicalTrials.gov Identifier: NCT02384967   History of Changes  
Other Study ID Numbers: ANRS 165 DARULIGHT  
Study First Received: February 23, 2015  
Last Updated: January 23, 2017  

Additional relevant MeSH terms:
HIV Infections
Darunavir

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.