Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

Study Overview
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Brief Summary
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The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.

Detailed Description
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The main objective of this study is 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 week in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.

Official Title
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Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

Conditions
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HIV

Intervention / Treatment
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* Drug: ATRIPLA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥ 18 years) HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years. Standard plasma viral load below the limit of detection for at least 2 years. CD4 count above 350/mm3 at the time of the consideration for the study. 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. Patients should be given written informed consent In the opinion of the investigator, be able to follow the design of the protocol visits Exclusion Criteria: Patients who have experienced virologic failure prior to any antiretroviral regimen Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study Any contraindication to study drug Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient Uncontrolled preexisting psychiatric illness Any current sign of alcoholism or other drug use.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATRIPLA three times a week.<br>Atripla (600 mg/200 mg/245 mg) three times a week. | Drug: ATRIPLA<br> <br> * Other names: mg/245 mg;|
| Active Comparator: ATRIPLA one time a day.<br>Atripla (600 mg/200 mg/245 mg) one time a day. | Drug: ATRIPLA<br> <br> * Other names: mg/245 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks. |  | 24 weeks | 
| The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells |  | baseline and 6 months | 
| Immunological | 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. | baseline and 6 months | 
| Changes in plasma levels of efavirenz. |  | baseline and 6 months | 
| Changes in sleep quality (Pittsburgh Sleep Quality Index). |  | baseline and 6 months | 
| General Safety (report adverse events, serious adverse events and treatment discontinuation due to adverse events) |  | 24 weeks | 
| Changes in plasma levels of vitamin D. |  | baseline and 6 months | 
| Changes in lipid profile. |  | baseline and 6 months | 
| Changes in estimated glomerular filtration rate. |  | baseline and 6 months |