A clinical trial comparing the efficacy and tolerability of two maintenance therapy strategies: lopinavir/ritonavir monotherapy or once-daily triple therapy with efavirenz/emtricitabine/tenofovir in HIV-1-infected patients with a plasma HIV-1 RNA level below 50 copies/ml. - DREAM

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Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: Kaletra Product Name: Kaletra Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Lopinavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐mg INN or Proposed INN: ritonavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐mg Trade Name: Atripla Product Name: Atripla Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Efavirenz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐mg INN or Proposed INN: Emtricitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐mg INN or Proposed INN: Tenofovir disoproxil (in the form of fumarate) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245 mg CONDITION: HIV infection; MedDRA version: 11.0 Level: LLT Classification code 10020161 Term: PRIMARY OUTCOME: Main Objective: To compare the individual efficacy of two maintenance therapy strategies over a 2-year period: lopinavir/ritonavir monotherapy or fixed triple therapy with efavirenz/emtricitabine/tenofovir in patients with controlled plasma HIV-1 RNA levels. Primary endpoint(s): The primary endpoint is the proportion of patients without strategy failure at week 96. Strategy failure at week 96 is defined by: - ​​an HIV RNA ≥ 50 copies/mL at week 96, confirmed at week 98 - or discontinuation of the trial strategy - or the occurrence of death or a C-classified event in the HIV infection classification. Secondary Objective: To compare the two groups from week 00 to week 96 on: - virological response and its durability at thresholds of 50 and 400 copies/mL, - the evolution of CD4+ T lymphocytes, - clinical and biological tolerance, - the occurrence of a plasma HIV-1 RNA ≥ 400 copies/mL confirmed by two measurements and the occurrence of HIV-1 resistance mutations in the case of HIV-1 RNA ≥ 400 copies/mL, - the proportion of patients presenting with lipodystrophic syndrome or metabolic syndrome, - adherence measured by self-questionnaire, - changes in quality of life, - prevalence of mild cognitive impairment and moderate cognitive disorders, - cost of treatments and monitoring; Study the determinants of the durability of the virological response; Study the relationships between pharmacokinetics and pharmacodynamics and/or pharmacogenetics based on the results of the trial. INCLUSION CRITERIA: Patients aged 18 years or older, infected with HIV-1, - stable ART for 6 months, - HIV-1 RNA < 50 copies/ml for at least 12 months, CD4+ > 200/mm3, - CD4+ lymphocyte nadir > 100/mm3, - no history of virological failure, - no documented mutation conferring resistance to NRTIs or NNRTIs, no documented primary protease mutation, - informed and signed consent, - affiliated with or beneficiary of a social security scheme. 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 F.1.3 Elderly (>=65 years) yes.
Epistemonikos ID: e3b943d4906305762da9c7e086db7fdfd3f75300
First added on: Aug 22, 2024
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