Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 … (NCT02212379) | Clinical Trial Compass
CompletedPhase 2
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
France170 participantsStarted 2015-01
Plain-language 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 virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load \>50 copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy \>90%, assuming a success rate \>95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96.
Who can participate
Age range45 Years
SexALL
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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 (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…
What they're measuring
1
Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96