SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by St Stephens Aids Trust
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT02219217
First received: August 14, 2014
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

The purpose of the study is to look at the levels of three HIV medications: dolutegravir, elvitegravir and cobicistat 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 after taking them every day for 10 days dolutegravir on a first stage and a combination of elitegravir and cobicistat in a second stage.

If the participant decides to take part, the duration of the study will be up to 38 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit which takes place 7 to 14 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 the participant is taking at all times during the study.


Condition Intervention Phase
HIV
Drug: Dolutegravir, Elvitegravir and Cobicistat
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics of DOLUTEGRAVIR Once Daily and ELVITEGRAVIR/COBICISTAT 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:
  • Steady state plasma concentrations of dolutegravir and elvitegravir/cobicistat after drug intake cessation up to 216 hours post-dose. [ Time Frame: 216 hours ] [ Designated as safety issue: No ]

    On days 10 and 29: Serial blood specimens will be obtained from each participant for determining drug concentrations of dolutegravir or elvitegravir /cobicistat at the following time points: pre dose (within 10 minutes before dosing), 2, 4, 8 and 12 hours post dose (+/- 5 minutes time window for all post dose time points).

    On days 11-12 and 30-31: Participants will have to attend the unit twice each day, in the mornings and evenings to provide the 24, 36, 48 and 60 hour post dose samples respectively, in order to determine drug concentrations.

    On days 13 to 19 and 32 to 38: Blood will be drawn at the following time points: 72, 96, 120, 144, 168, 192 and 216 hours post last drug dose (dolutegravir and elvitegravir/cobicistat respectively).



Estimated Enrollment: 16
Study Start Date: October 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No arms
Open label, PK study.
Drug: Dolutegravir, Elvitegravir and Cobicistat

  Eligibility

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

Inclusion Criteria

  • 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
  • ALT, alkaline phosphatase and bilirubin 1.5xULN (isolated bilirubin greater 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin lesser than 35 per cent). A single repeat is allowed for eligibility determination.
  • 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

A female may be eligible to enter and participate in the study if she:

  • is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
  • is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: (please see protocol)
  • Willing to consent to their personal details being entered onto the TOPS database
  • Willing to provide proof of identity by photographic ID at screen and any subsequent visit
  • Registered with a GP in the UK

Exclusion Criteria

  • Any clinically 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 or C antibodies
  • Positive blood screen for HIV-1 or 2 by antibody/antigen assay
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • History or presence of allergy to DTG or excipients (D-Mannitol, Microcystalline Cellulose, Povidone, Croscarmellose Sodium, Sodium Stearyl Fumarate, Talc, white film coat)
  • Current or recent (within 3 months) gastrointestinal disease
  • Known intolerance of 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) or participation in a clinical study involving the donation of blood samples 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
  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: NCT02219217

Contacts
Contact: Marta Boffito, MD 0044(0)2033156507 marta.boffito@chelwest.nhs.uk

Locations
United Kingdom
St Stephen's AIDS Trust Recruiting
London, United Kingdom, SW10 9NH
Principal Investigator: Marta Boffito, MD         
Sponsors and Collaborators
St Stephens Aids Trust
ViiV Healthcare
  More Information

No publications provided

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT02219217     History of Changes
Other Study ID Numbers: SSAT061
Study First Received: August 14, 2014
Last Updated: November 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dolutegravir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2015