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

HIV INFECTION Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384967
• Other study ID #: ANRS 165 DARULIGHT
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2015
• Last updated: January 23, 2017
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV INFECTION
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

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