PK of Tenofovir, Emtricitabine and Efavirenz in Healthy Volunteers - Full Text View

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Efavirenz Tenofovir Disoproxil Fumarate Atripla

U.S. FDA Resources

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®

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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:

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
Male or non-pregnant, non-lactating females
Between 18 to 65 years, inclusive
Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
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
Willing to consent to their personal details being entered onto The Over volunteering Prevention Scheme (TOPS) database
Willing to provide photographic identification at each visit.
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.

Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Positive blood screen for hepatitis B surface antigen and/or C antibodies
Positive blood screen for HIV-1 and/or 2 antibodies
Current or recent (within 3 months) gastrointestinal disease
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
Exposure to any investigational drug or placebo within 3 months of first dose of study drug
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.
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
Previous allergy to any of the constituents of the pharmaceuticals administered in this trial

Contacts and Locations

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:

St Stephen's AIDS Trust website This link exits the ClinicalTrials.gov site

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:

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
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 May 19, 2013