ANRS 163 ETRA

Phase 1

• Conditions: HIV infection; MedDRA version: 18.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000828-24-ES
• Lead Sponsor: Inserm-ANRS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Documented HIV-1 infection.
- Age ? 45 years.
- Naïve to integrase inhibitor and etravirine.
- At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs.
- HIV-RNA plasma VL ? 50 copies/mL during the last 24 months prior to screening visit (W-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies/mL.
- HIV-RNA plasma VL ? 50 copies/mL at screening visit (W-4).
- Absence of any documented NNRTI (Non-Nucleosidic Reverse Transcriptase Inhibitor) mutation other than K103N at any time in medical history.
- Full sensitivity of ETR in HIV DNA genotypic resistance test.
- CD4+ lymphocytes > 200 cells/mm3.
- Creatinine < 2.5 x ULN.
- CPK (Creatine Phospho Kinase) < 6 ULN.
- AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) < 5 ULN.
- Hemoglobin > 10 g/dL.
- Platelets > 100 000/mm3.
- Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential.
- For French participants only: patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
- Patients with a coverage from a social health.
- Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Previous exposure to raltegravir or etravirine.
- Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac.
- HIV-2 infection.
- Active viral hepatitis C requiring a specific treatment during the 24 months of the trial.
- Patient with a history of non-compliance or irregular follow-up.
- Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or anti-diabetic treatment within the last 3 months prior the screening visit (W-4).
- Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John?s wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra?), Triazolam (Halcion®).
- Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy.
- Concomitant prophylactic or curative treatment for an opportunistic infection.
- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance.
- Subjects under sauvegarde de justice (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
- Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.
- Pregnant women or breastfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified