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Aplaviroc Phase 3 in Treatment-Experienced HIV

NCT00297076Phase 3

Key facts

Status: Terminated
Start: Jul 2005
Primary completion: Oct 2007
Countries: 1
Sponsor: GSK
Modality: Small Molecules

Drugs: aplaviroc
Conditions: human immunodeficiency virus infection (HIV)

Overview

Phase 3, randomised, double-blind trial in human immunodeficiency virus infection (HIV) comparing Aplaviroc + OBT with Placebo + OBT (2 arms). Primary endpoint: HIV viral load response at 48 weeks. Started Jul 2005; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Aplaviroc + OBT
GW873140 400mg BID + Optimized Background Therapy (including Ritonavir-boosted PI)
Placebo + OBT
Placebo + Optimized Background Therapy (including Ritonavir-boosted PI)

Who it enrols

HIV-1 infected adults with R5-tropic virus, viral load >= 5000 copies/mL, and documented resistance to NRTIs, NNRTIs, and PIs. Must be on a stable pre-study regimen and able to construct an OBT with a ritonavir-boosted PI.

Endpoints

Primary

HIV viral load response48 weeks

Secondary

Safety and tolerability48 weeks
Change in T-cell count48 weeks
Disease progression48 weeks
Viral resistance48 weeks
Tropism at failure48 weeks
Pharmacokinetics48 weeks
Health outcomes48 weeks
Adherence48 weeks

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