Overview

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.