PK of Tenofovir, Emtricitabine and Efavirenz in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108926
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : November 1, 2010
Information provided by:
St Stephens Aids Trust

Brief Summary:

The purpose of the study is to look at the levels of three HIV medications: tenofovir, emtricitabine, and efavirenz in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for 14 days.

This study is not randomised which means that all subjects will receive all study medications in the same order. You and the study doctor will know which study medications you are taking at all times during the study.

Condition or disease Intervention/treatment Phase
HIV Infection HIV Infections Drug: Atripla® Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Efavirenz Once Daily Over 10 Days Following Drug Intake Cessation in Healthy Volunteers
Study Start Date : June 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: All Subjects
All Subjects will receive the same intervention
Drug: Atripla®
All subjects will be administered Atripla® (tenofovir 245 mg plus emtricitabine 200 mg plus efavirenz 600 mg), one tablet orally once daily for 14 days
Other Names:
  • tenofovir = Viread®
  • emtricitabine = Emtriva® (formerly Coviracil)
  • tenofovir + emtricitabine = Truvada®
  • efavirenz = Sustiva® and Stocrin®

Primary Outcome Measures :
  1. pharmacokinetics of plasma tenofovir, emtricitabine and efavirenz [ Time Frame: 24 days ]
    To assess the pharmacokinetics of plasma tenofovir and emtricitabine, and their active intracellular anabolites, tenofovir-diphosphate and emtricitabine-triphosphate, and plasma efavirenz over 10 days following drug intake cessation, in HIV negative healthy volunteers

Secondary Outcome Measures :
  1. inter subject variability [ Time Frame: 24 days ]
    To assess the inter subject variability in the concentrations of plasma tenofovir and emtricitabine, and their active intracellular anabolites, and plasma efavirenz following drug intake cessation

  2. safety and tolerability of Atripla® [ Time Frame: 24 days ]
    To assess the safety and tolerability of Atripla® over 14 days of administration in HIV negative healthy volunteers

  3. pharmacogenetic [ Time Frame: 24 days ]
    To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria within 28 days prior to the baseline visit:

  1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
  2. Male or non-pregnant, non-lactating females
  3. Between 18 to 65 years, inclusive
  4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
  5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 12 weeks after the study
  6. Willing to consent to their personal details being entered onto The Over volunteering Prevention Scheme (TOPS) database
  7. Willing to provide photographic identification at each visit.
  8. Registered with a GP in the UK

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

  1. Any significant acute or chronic medical illness
  2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
  3. Positive blood screen for hepatitis B surface antigen and/or C antibodies
  4. Positive blood screen for HIV-1 and/or 2 antibodies
  5. Current or recent (within 3 months) gastrointestinal disease
  6. Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
  7. Exposure to any investigational drug or placebo within 3 months of first dose of study drug
  8. Use of any other drugs (unless approved by the Investigator), including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
  9. Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 12 weeks after the end of the treatment period
  10. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial

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 identifier (NCT number): NCT01108926

United Kingdom
St Stephen's Centre
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
St Stephens Aids Trust
Principal Investigator: Marta Boffito, Dr St Stephen's AIDS Trust

Additional Information:
Responsible Party: Dr Marta Boffito, St Stephen's AIDS Trust Identifier: NCT01108926     History of Changes
Other Study ID Numbers: SSAT 035
2009-018055-16 ( EudraCT Number )
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Efavirenz, 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