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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 08, 2014