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PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers

NCT02631473 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-12-07

No results posted yet for this study

Summary

This study is an open-label, prospective pharmacokinetic study investigating two antiretroviral agents in parallel and employing an adaptive design with two stages, whereby the results obtained in the primary stage inform the doses selected for investigation in the secondary stage

Conditions

Interventions

DRUG

50mg NANO-efavirenz

OD

DRUG

400mg NANO-Lopinavir

BID

DRUG

200mg NANO-Lopinavir

BID

DRUG

100mg Ritonavir

BID

DRUG

300mg NANO-Efavirenz

OD

DRUG

600mg Sustiva

OD

DRUG

200mg NANO-Efavirenz

OD

DRUG

Kaletra® (lopinavir 400mg/ritonavir 100mg)

BID

DRUG

+/- 200mg NANO-Lopinavir

BID

DRUG

+/- 200mg ritonavir NORVIR

BID

DRUG

400mg Sustiva

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito · Chelsea & Westminster Hospital

  • Steve Rannard · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631473 on ClinicalTrials.gov