Status:
COMPLETED
SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers
Lead Sponsor:
St Stephens Aids Trust
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02219217
Start Date
October 1 2014
End Date
January 1 2015
Last Update
August 15 2016
Active Locations (1)
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1
St Stephen's AIDS Trust
London, London, United Kingdom, SW10 9NH