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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Cobicistat; Darunavir; Dolutegravir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Age ≥ 18 years at screening visit.

• Patients with primary HIV-1 infection: Any results achieved in the previous 10 days of inclusion visit will be taken into account. If the Enzyme Linked ImmunoSorbent Assay (ELISA) test result does not dissociate the signals antibodies and p24 antigen or in case of rapid test result :

• 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.

Exclusion Criteria:

• Any antiretroviral treatment (for Pre-Exposure Prohylaxis or Post-exposure prophylaxis) during the 4 weeks preceding inclusion.

• 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.

• Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.

• 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.