HIV -1 infection MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Atripla 600 mg/200 mg/245 mg comprimidos recubiertos con película.
Product Name: ATRIPLA
Pharmaceutical Form: Coated tablet
Sponsors
Fundació Clinic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (= 18 years) 2. HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years. 3. Standard plasmárica viral load below the limit of detection for at least 2 years. 4. CD4 count above 350/mm3 at the time of the consideration for the study. 5. Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug. 6. Patients should be given written informed consent 7. In the opinion of the investigator, be able to follow the design of the protocol visits 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have experienced virologic failure prior to any antiretroviral regimen 2. Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine 3. Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study 4. Any cointraindicación to study drug 5. Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient 6. Uncontrolled preexisting psychiatric illness 7. Any current sign of alcoholism or other drug use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study was to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per weeks in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.;Secondary Objective: ? virological study including: ultrasensitive viral load in plasma (limit of detection 1 copy / mL), and HIV-1 reservoir mononucelares cells from peripheral blood, ? immune Study includes TRECs production, immune profile of activation (CD38 and HLA-DR) and senescence (CD57 and CD28) in the CD4 and CD8 lineage, apoptosis (annexin V staining), and naive T-cell ratios and effector and memory (CCR7 and CD45RA). ? Pharmacokinetic study, including basal plasma levels of efavirenz at the beginning and end of study. ? Safety study, including: test on sleep quality (Pittsburgh Sleep Quality Index), levels of vitamin-D 25OH, estimated glomerular filtration rate (CPK-EPI) and lipids (triglycerides, total cholesterol and HDL) plasma at the beginning and at end of study and overall tolerability.;Primary end point(s): The primary endpoint will be the proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks. 2) The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells 3) Changes from baseline to 24 weeks in the production of TRECs, the immunological profile of activation (CD38 and HLA-DR) and senescence (CD57 and CD28) in CD4 and CD8 lineages in the proportions of naive T cells effector and memory (CCR7 and CD45RA), and changes in the levels of apoptosis in vitro by staining with annexin V. 4) Changes in plasma levels of efavirenz. 5) Changes in sleep quality (Pittsburgh Sleep Quality Index), plasma levels of vitamin D and lipids, and estimated glomerular filtration rate. 6) General Security (report side effects, serious side effects and treatment discontinuation due to side effects);Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Spain
Contacts
Public ContactCTU
CTU- Clinical Trial unit. Farmacologia clinica
Outcome results
None listed