GW873140 In Combination With Kaletra In HIV Infected Subjects

Phase 2

Terminated

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

• Registration Number: NCT00102778
• Lead Sponsor: ViiV Healthcare

Brief Summary

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

Detailed Description

A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-02-01
• Study First Submitted QC: 2005-02-01
• Study First Posted: 2005-02-02
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom