A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term
Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared
to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2
wks with Long-Term Evaluation (>48 wks) of Safety, PK and Antiviral Activity of Selected
GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

Inclusion criteria:

- 18+ years of age (or =16 years of age for non-EU countries, according to local
requirements).

- 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.

- Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months
of Screening.

- Subjects must have been receiving the same anti-HIV medicines that they are on
currently for at least 8 weeks prior to Screening; these anti-HIV medicines will
include a single protease inhibitor (PI) in combination with a low dose of ritonavir
(i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.

- Able to understand and follow protocol requirements, instructions and protocol-stated
restrictions.

- Be willing and able to provide signed and dated written informed consent prior to
study entry.

Exclusion criteria:

- Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.

- Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse
transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.

- Active CDC Class C disease at screening.

- Pregnant or breastfeeding women.

- Protocol-specified laboratory abnormalities at Screening.