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

This study is currently recruiting participants.
Verified May 2013 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01778413
First received: January 18, 2013
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
HIV
 Drug: ATRIPLA
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Immunological [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
    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 plasma levels of efavirenz. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in sleep quality (Pittsburgh Sleep Quality Index). [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • General Safety (report adverse events, serious adverse events and treatment discontinuation due to adverse events) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in plasma levels of vitamin D. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in lipid profile. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in estimated glomerular filtration rate. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778413

Contacts
Contact: Anna Cruceta, MD 932275400 ext 4380 acruceta@clinic.ub.es

Locations
Spain
Hospital Clinic i Provincial Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Anna Cruceta, MD     0034932275400 ext 4380     acruceta@clinic.ub.es    
Principal Investigator: Esteban Martinez, MD            
Sponsors and Collaborators
Anna Cruceta
Investigators
Principal Investigator: Esteban Martinez, MD Hospital Clínic i Provincial de Barcelona
  More Information

No publications provided

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
Study First Received: January 18, 2013
Last Updated: May 13, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Efavirenz
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 18, 2013