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

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ClinicalTrials.gov Identifier: NCT01778413
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
HIV Drug: ATRIPLA Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
Study Start Date : May 2013
Primary Completion Date : November 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778413


Locations
Spain
Hospital Clinic i Provincial Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Anna Cruceta
Investigators
Principal Investigator: Esteban Martinez, MD Hospital Clínic i Provincial de Barcelona
More Information

Responsible Party: Anna Cruceta, Project manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01778413     History of Changes
Other Study ID Numbers: A-TRI-WEEK
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: May 2013

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Efavirenz
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers