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

NCT01778413 | Completed Phase 4 Results

• 1 other identifier: A-TRI-WEEK
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  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

Study Arms (2)

ATRIPLA three times a week.

EXPERIMENTAL

Atripla (600 mg/200 mg/245 mg) three times a week.

Drug: ATRIPLA

ATRIPLA one time a day.

ACTIVE COMPARATOR

Atripla (600 mg/200 mg/245 mg) one time a day.

Drug: ATRIPLA

Interventions

ATRIPLA DRUG

Also known as: efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200, mg/245 mg

ATRIPLA one time a day.; ATRIPLA three times a week.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Cruceta: lead

Study Sites (1)

Hospital Clinic i Provincial Barcelona

Barcelona, 08036, Spain

Location

Related Publications (2)

• 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.

  PMID: 30946150 DERIVED

• 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.

  PMID: 29746294 DERIVED

MeSH Terms

Interventions

Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; efavirenz; Emtricitabine; Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

This was a single-center, open-label, pilot study with a small sample size (N=61) and short follow-up (24 weeks). The study was not powered to detect rare adverse events or long-term outcomes. No formal non-inferiority analysis was conducted.

Results Point of Contact

• Title: Dr. Esteban Martinez
• Organization: Hospital Clínic de Barcelona

estebanm@clinic.cat

932275400

Study Officials

• Esteban Martinez, MD

  Hospital Clínic i Provincial de Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 29, 2013
• Study Start: June 3, 2013
• Primary Completion: November 14, 2014
• Study Completion: July 21, 2015
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-07

Locations

ES (1)