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

NCT02384967 | Completed Phase 2 DMC

• 1 other identifier: ANRS 165 DARULIGHT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV INFECTION

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  Week 48

• Proportions of patients with VL < 50 cp/ml

  Week 12, Week 24, Week 36, Week 48

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

  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

  Week 12, Week 24, Week 36, Week 48

• Change from baseline in blood HIV DNA at week 48

  Week 48

Study Arms (1)

Darunavir 400mg/d

EXPERIMENTAL

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

Drug: Darunavir

Interventions

Darunavir 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.

Also known as: Prezista

Darunavir 400mg/d

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Hôpital Saint Louis

Paris, 75010, France

Location

Related Publications (1)

• 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.

  PMID: 29905808 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 10, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

FR (1)