Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine (A-TRI-WEEK)
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|ClinicalTrials.gov Identifier: NCT01778413|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: ATRIPLA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
Experimental: ATRIPLA three times a week.
Atripla (600 mg/200 mg/245 mg) three times a week.
Active Comparator: ATRIPLA one time a day.
Atripla (600 mg/200 mg/245 mg) one time a day.
- Proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis. [ Time Frame: 24 weeks ]
- The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks. [ Time Frame: 24 weeks ]
- The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells [ Time Frame: baseline and 6 months ]
- Immunological [ Time Frame: baseline and 6 months ]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.
- Changes in plasma levels of efavirenz. [ Time Frame: baseline and 6 months ]
- Changes in sleep quality (Pittsburgh Sleep Quality Index). [ Time Frame: baseline and 6 months ]
- General Safety (report adverse events, serious adverse events and treatment discontinuation due to adverse events) [ Time Frame: 24 weeks ]
- Changes in plasma levels of vitamin D. [ Time Frame: baseline and 6 months ]
- Changes in lipid profile. [ Time Frame: baseline and 6 months ]
- Changes in estimated glomerular filtration rate. [ Time Frame: baseline and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778413
|Hospital Clinic i Provincial Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Esteban Martinez, MD||Hospital Clínic i Provincial de Barcelona|