NCT00144833|TerminatedPhase 3DMC

Study Stopped

Incomplete data

Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects

A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

APV102002

Study Type

interventional

Target

150

Locations

9 countries

Sites

Timeline

RegisteredSep 2005

StartedMar 2005

Brief Summary

For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach

9 countries

42 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed

Last Updated

November 12, 2007

Status Verified

November 1, 2007

First QC Date

September 1, 2005

Last Update Submit

November 9, 2007

Conditions

HIV-1

Keywords

Protease inhibitors-experienced HIV-1 infected patientsHighly-resistant HIV-1Dual boosted Pisfosamprenavirlopinavir

Outcome Measures

Primary Outcomes (1)

The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.
24 weeks

Secondary Outcomes (1)

Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.
48 weeks

Interventions

fosamprenavir/ritonavir (700mg/100mg BID)DRUG

fosamprenavir/ritonavir (1400mg/100mg BID)DRUG

fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests.

You may not qualify if:

No full resistance to FPV/r or LPV/r
Planned use of NNRTIs as part of the study salvage regimen

Contact the study team to confirm eligibility.