National Multicenter Trial Evaluating Two Treatments in Patients with Primary Human Immunodeficiency Virus (HIV-1) Infection

NCT02987530 | Completed Phase 3 DMC

• 2 other identifiers: ANRS 1692016-001683-11
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection.

Conditions

HIV-1 Infection

Keywords

primary infection

Outcome Measures

Primary Outcomes (1)

• HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48

  week 48

Secondary Outcomes (23)

• Cumulative cellular viremia up to week 48

  week 48

• Cumulative plasmatic viremia (HIV-1 RNA) at week 48

  week 48

• Cumulative plasmatic viremia using the values obtained by ultrasensitive quantification for all HIV-1-RNA values < 50 copies / mL.

  week 48

• Levels of HIV-1 RNA in plasma at week 2, week 4, week 8, week 12, week 24, week 36, week 48 and changes between week 0 and week 48

  week 2, week 4, week 8, week 12, week 24, week 36, week 48

• Percentage of patients with HIV-1 RNA <50 copies / mL at week 2, week 4, week 8, week 12, week 24, week 36, week 48

  week 2, week 4, week 8, week 12, week 24, week 36, week 48

Study Arms (2)

Dolutegravir + Emtricitabine/Tenofovir

EXPERIMENTAL

Patients will take Dolutegravir 50 mg (= Tivicay, 1 tablet per day) with Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks

Drug: Dolutegravir; Drug: Emtricitabine-Tenofovir

Darunavir/Cobicistat + Emtricitabine/Ténofovir

ACTIVE COMPARATOR

Patients will take Darunavir 800 mg / Cobicistat 150 mg (=Rezolsta, 1 tablet per day) + Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks

Drug: Darunavir-cobicistat; Drug: Emtricitabine-Tenofovir

Interventions

Dolutegravir DRUG

Oral use, 50mg/day

Also known as: Tivicay

Dolutegravir + Emtricitabine/Tenofovir

Darunavir-cobicistat DRUG

Oral use, 800-150mg/day

Also known as: Rezolsta

Darunavir/Cobicistat + Emtricitabine/Ténofovir

Emtricitabine-Tenofovir DRUG

Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg

Also known as: Truvada

Darunavir/Cobicistat + Emtricitabine/Ténofovir; Dolutegravir + Emtricitabine/Tenofovir

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years at screening visit.
• Negative ELISA / rapid test and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA.
• Positive ELISA / rapid test and WB-HIV1 \[0-5\] band (s) or IB-HIV-1 \[0-3\] band(s) confirmed by a positive HIV-1 RNA.
• If the ELISA test result dissociated p24 antigen and antibodies signals:
• ELISA Ac - / p24 - and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA.
• ELISA Ac - / p24 + confirmed by a positive HIV-1 RNA.
• ELISA Ac + / p24 + or - and WB-HIV1 \[0-5\] band (s) or IB-HIV-1 \[0-3\] band(s) confirmed by a positive HIV-1 RNA.
• Written informed consent signed by the person and the investigator no later than the day of the screening visit and before any exam performed in the trial (article L1122-1-1 Public Health Code).
• Affiliate or beneficiary of a social security system (Article L1121-11 of the Public Health Code) (the State Medical Aid or AME is not a social security system).
• Patients followed in selected centers, accepting additional constraints and having signed a consent, will participate to virological, immunological and pharmacological sub-studies.
• Patient agreeing to participate in the trial for 1 year according to the defined terms.

You may not qualify if:

• Associated pathology with urgent care needed.
• Prothrombin Ratio \< 50%.
• Creatinine clearance \< 70 mL / min (Cockroft).
• aspartate transaminase (AST), alanine transaminase (ALT), or bilirubin (total and conjugated) ≥ 10 times the upper limit of normal.
• Patient with isolated HIV-2 viral strain.
• Women of childbearing potential without effective contraception method (see appendix A6).
• Pregnant or breastfeeding women.
• Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
• Planned absence which could prevent optimal trial participation (vacation abroad, moving, imminent job change ...).
• Co-administration of prohibited treatments (see § 9.5).
• History or presence of allergy to the study drugs or their components;
• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
• Any symptoms or laboratory values suggesting a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions that could interfere with the interpretation of trial results or compromise the health of patients.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hopital Bicetre

All the Regions of the Country (40 Centers), France

Location

MeSH Terms

Interventions

dolutegravir; cobicistat mixture with darunavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Antoine Chéret, MD, PhD

  Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 9, 2016
• Study Start: April 11, 2017
• Primary Completion: July 30, 2019
• Study Completion: January 31, 2020
• Last Updated: December 27, 2024

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)