Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine (A-TRI-WEEK)

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATRIPLA three times a week.; Atripla (600 mg/200 mg/245 mg) three times a week.	Drug: ATRIPLA; Other Names: efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200; mg/245 mg
Active Comparator: ATRIPLA one time a day.; Atripla (600 mg/200 mg/245 mg) one time a day.	Drug: ATRIPLA; Other Names: efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200; mg/245 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks.	Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that could make the doctor in charge consider the cessation of the study.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Anna Cruceta
• Investigators: Principal Investigator: Esteban Martinez, MD, Hospital Clinic i Provincial de Barcelona

Publications and helpful links

General Publications

• Guardo AC, Zarama A, Gonzalez T, Bargallo ME, Rojas J, Martinez E, Plana M, Sanchez-Palomino S. Effects on immune system and viral reservoir of a short-cycle antiretroviral therapy in virologically suppressed HIV-positive patients. AIDS. 2019 May 1;33(6):965-972. doi: 10.1097/QAD.0000000000002169.
• Rojas J, Blanco JL, Sanchez-Palomino S, Marcos MA, Guardo AC, Gonzalez-Cordon A, Lonca M, Tricas A, Rodriguez A, Romero A, Miro JM, Mallolas J, Gatell JM, Plana M, Martinez E. A maintenance 3-day-per-week schedule with the single tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate is effective and decreases sub-clinical toxicity. AIDS. 2018 Jul 31;32(12):1633-1641. doi: 10.1097/QAD.0000000000001843.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2013
• Primary Completion (Actual): November 14, 2014
• Study Completion (Actual): July 21, 2015

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimated): January 29, 2013

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2C19 Inhibitors; Tenofovir; Emtricitabine; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Efavirenz
• Other Study ID Numbers: A-TRI-WEEK