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

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: ATRIPLA

• Registration Number: NCT01778413
• Lead Sponsor: Anna Cruceta

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Status Verified: 2013-05
• Study Start: 2013-05
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATRIPLA three times a week.	ATRIPLA	Atripla (600 mg/200 mg/245 mg) three times a week.
ATRIPLA one time a day.	ATRIPLA	Atripla (600 mg/200 mg/245 mg) one time a day.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks.	24 weeks
Changes in plasma levels of efavirenz.	baseline and 6 months
The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells	baseline and 6 months
Immunological	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 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

Trial Locations

Locations (1)

Hospital Clinic i Provincial Barcelona; 🇪🇸 Barcelona, Spain