PK of Efavirenz & Lopinavir Nano-Formulations in Healthy Volunteers
Research type
Research Study
Full title
Pharmacokinetics of efavirenz and lopinavir nano-formulations in HIV negative healthy volunteers: an adaptive design study
IRAS ID
167816
Contact name
Marta Boffito
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2013-004913-41
Clinicaltrials.gov Identifier
15/LO/0424, REC Reference
Duration of Study in the UK
1 years, 0 months, days
Research summary
The purpose of this study is to explore two antiretroviral (HIV-suppressing) treatments options at the same time, and taking on a trial design with two stages that change, whereby the results gathered in the primary stage informs the doses chosen for investigation in the secondary stage.
Current antiretroviral treatments are given in long term (chronic) doses and administered at least daily over several decades to suppress viral replication. Patient adherence to therapy is critical in preventing viral resistance, but even in patients with good adherence, the amount of active drug available in the body (bioavailability) of many antiretrovirals is low and the movement of the drug within the body (pharmacokinetics) are variable. Nanoformulation offers many potential advantages such as modified administration routes, reduced cost, reduced toxicity wider tolerability and increased patient adherence. We are producing nanomedicines from current antiretrovirals and exploring their potential clinical benefits. We are now exploring how the physicochemical properties of nanomedicines relate to their pharmacological and toxicological properties.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0424
Date of REC Opinion
13 Apr 2015
REC opinion
Further Information Favourable Opinion