Status:
COMPLETED
Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Janssen-Cilag Ltd.
Conditions:
HIV-1 Infection
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virol...
Eligibility Criteria
Inclusion
- 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 (Week-6/Week-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 (Week-6/Week-4)
- A genotype is available (on amplified DNA at Week-6/Week-4 Visit and/or on RNA in the medical history of the patient) and shows a virus sensitive to ETR OR no genotype is available (amplification failure on DNA at Week-6/Week-4 Visit and no genotype in the medical history of the patient), there are no virological failure on NNRTI in the medical history
- CD4+ lymphocytes \> 200 cells/mm3
- Creatinine \< 2.5 x ULN
- CPK (Creatine Phospho Kinase) \< 6 ULN (Upper Limit of Normal)
- 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: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme), article L1121-11 of the Public health code
- Patients with a coverage from a social health
- Signed informed consent
Exclusion
- Previous exposure to raltegravir or etravirine
- Presence of any documented integrase inhibitor mutation on DNA genotype at Week-6/Week-4 and/or on RNA in the medical history of the patient
- 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 antidiabetic treatment within the last 3 months prior the screening visit (Week-6 /Week-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 immunotherapy 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 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT02212379
Start Date
January 1 2015
End Date
April 1 2018
Last Update
April 27 2021
Active Locations (19)
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1
Hôpital Avicenne
Bobigny, France, 93000
2
Hôpital Jean Verdier
Bondy, France, 93140
3
Hôpital Saint André
Bordeaux, France, 33076
4
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275