A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

HIV Infection

Infection, Human Immunodeficiency Virus

Treatments

Drug: Half-boosted Fosamprenavir

Drug: Full Boosted Fosamprenavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00363142

LEX106430

Details and patient eligibility

About

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

Full description

A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)

Enrollment

211 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with HIV-1 infection.
Are willing and able to understand and provide written consent prior to participation in this study.

Exclusion criteria

Are pregnant or breastfeeding.
Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
Have certain medical conditions that may make participation unsafe.
Take medication that may interact with the study medication.
Have a history of allergy to any of the study drugs or any excipients therein.
Other inclusion/exclusion criteria to be evaluated by the physician.