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OpenTrials
Completed

NCT Number: NCT01778413

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

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

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic i Provincial Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATRIPLA

Drug

Other names: efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg/200, mg/245 mg

Primary outcomes

  1. Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks.

    Time frame: 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.

Secondary outcomes

  1. The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks.

    Time frame: 24 weeks

  2. The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells

    Time frame: baseline and 6 months

  3. 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.

  4. Changes in Plasma Levels of Efavirenz.

    Time frame: baseline and 6 months

  5. Changes in Sleep Quality (Pittsburgh Sleep Quality Index).

    Time frame: baseline and 6 months

  6. General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events)

    Time frame: 24 weeks

  7. Changes in Plasma Levels of Vitamin D.

    Time frame: baseline and 6 months

  8. Changes in Lipid Profile.

    Time frame: baseline and 6 months

  9. Changes in Estimated Glomerular Filtration Rate.

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

Anna Cruceta

Other

Registry information

Acronym: A-TRI-WEEK

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 29, 2013
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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