A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

Phase 2

Terminated

• Conditions: Infection, Human Immunodeficiency Virus I; HIV-1 Infection

• Registration Number: NCT00242879
• Lead Sponsor: ViiV Healthcare

Brief Summary

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

Detailed Description

A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (\>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-21
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in laboratory parameters
Time averaged change in plasma HIV-1 RNA over 16 wks
Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse events
Changes in laboratory measurements
ECG measurements
HIV viral resistance assessment
Immunologic measures
Assessments of HIV viral load changes
GW640385 and RTV pharmacokinetic measurements

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom