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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 3

Conditions: HIV-1

Treatments: Drug: fosamprenavir/ritonavir (700mg/100mg BID); Drug: fosamprenavir/ritonavir (1400mg/100mg BID); Drug: fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144833

APV102002

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• No full resistance to FPV/r or LPV/r
• Planned use of NNRTIs as part of the study salvage regimen
• Application of additional exclusion criteria as determined by physician.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)