PK of Tenofovir, Emtricitabine and Efavirenz in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01108926
First received: April 21, 2010
Last updated: October 29, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
HIV Infection
HIV Infections
Drug: Atripla®
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • pharmacokinetics of plasma tenofovir, emtricitabine and efavirenz [ Time Frame: 24 days ] [ Designated as safety issue: No ]
    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:
  • inter subject variability [ Time Frame: 24 days ] [ Designated as safety issue: No ]
    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

  • safety and tolerability of Atripla® [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of Atripla® over 14 days of administration in HIV negative healthy volunteers

  • pharmacogenetic [ Time Frame: 24 days ] [ Designated as safety issue: No ]
    To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure


Enrollment: 19
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01108926

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

Additional Information:
No publications provided

Responsible Party: Dr Marta Boffito, St Stephen's AIDS Trust
ClinicalTrials.gov Identifier: NCT01108926     History of Changes
Other Study ID Numbers: SSAT 035, 2009-018055-16
Study First Received: April 21, 2010
Last Updated: October 29, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Emtricitabine
Communicable Diseases
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014