Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01796431
First received: February 20, 2013
Last updated: July 24, 2013
Last verified: July 2013

February 20, 2013
July 24, 2013
March 2013
July 2013   (final data collection date for primary outcome measure)
Plasma concentrations of tenofovir, emtricitabine and rilpivirine, and intracellular concentrations of tenofovir di-phosphate and emtricitabine tri-phosphate [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01796431 on ClinicalTrials.gov Archive Site
Safety and tolerability of Eviplera® [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of Eviplera over 14 days in HIV negative healthy volunteers.
Same as current
Genetic polymorphisms and exposure to Eviplera® [ Time Frame: 23 Days ] [ Designated as safety issue: No ]
To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure.
Same as current
 
Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers
Not Provided

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: Eviplera®
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.
Intervention: Drug: Eviplera®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01796431
SSAT 048
Not Provided
St Stephens Aids Trust
St Stephens Aids Trust
Not Provided
Not Provided
St Stephens Aids Trust
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP