GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults

A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults

This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.

Inclusion criteria:

• HIV-1 infected subjects.
• Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
• Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening.
• CD4+ cell count >/= 200 cells/mm3 at Screening.
• Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen.
• Willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

• Active CDC Class C disease.
• Pregnant or breastfeeding women.
• Protocol-specified laboratory abnormalities at Screening.
• Personal or family history of autoimmune disease.
• History or current indication of thyroid dysfunction or current thyroid gland abnormalities.