Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation 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: NCT01796431
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : July 25, 2013
Information provided by (Responsible Party):
St Stephens Aids Trust

Brief Summary:

The purpose of the study is to look at the levels of three HIV medications: tenofovir, emtricitabine, and rilpivirine 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.

The duration of the subjects involvement in the study will be up to 23 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 16-22 days after the last dose of study medication.

This study is not randomised which means that all participants will receive all study medications in the same order. The participant 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 Drug: Eviplera® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Eviplera

Arm Intervention/treatment
Experimental: Eviplera®
Participants will take Eviplera every day for 14 days. Levels of the active ingredients, Tenofovir disoproxil fumarate, emtricitabine, rilpivirine hydrochloride will be measured in in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood.
Drug: Eviplera®

Primary Outcome Measures :
  1. Plasma concentrations of tenofovir, emtricitabine and rilpivirine, and intracellular concentrations of tenofovir di-phosphate and emtricitabine tri-phosphate [ Time Frame: 23 days ]
    To assess the pharmacokinetics of plasma tenofovir (TFV) and emtricitabine (FTC), and their active intracellular anabolites, tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP), and plasma rilpivirine over 14 days following drug intake cessation, in HIV negative healthy volunteers

Secondary Outcome Measures :
  1. Safety and tolerability of Eviplera® [ Time Frame: 14 days ]
    To assess the safety and tolerability of Eviplera over 14 days in HIV negative healthy volunteers.

Other Outcome Measures:
  1. Genetic polymorphisms and exposure to Eviplera® [ Time Frame: 23 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:

  • 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
  • Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
  • 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

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): NCT01796431

United Kingdom
St Stephen's AIDS Trust
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
St Stephens Aids Trust

Responsible Party: St Stephens Aids Trust Identifier: NCT01796431     History of Changes
Other Study ID Numbers: SSAT 048
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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