This is a two phase study (randomized and non-randomized phase). The randomized phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomized to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomized phase to select for a dose of GW640385 to evalute further in Phase III studies. After dose selection subjects will move to the non-randomized phase of the study. In the non-randomzied phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

Condition	Intervention	Phase
HIV Infections	Drug: Physician determined comparator PI + ritonavir  Drug: GW640385 + ritonavir	Phase II

Further study details as provided by GlaxoSmithKline:

Primary Outcomes: Time averaged change in plasma HIV-1 RNA over 16 wks. Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels. Change in laboratory parameters.
Secondary Outcomes: Assessments of HIV viral load changes. GW640385 and RTV phamacokinetic measurements. The incidence of adverse events. Changes in laboratory measurements. ECG measurements. HIV viral resistance assessment. Immunologic measures.
Expected Total Enrollment:  130

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 infromed 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.

Location and Contact Information

Circle Medical LLC, Norwalk, Connecticut, 06851; Gary Blick, MD (203) 852-9525; Status: Recruiting
Or use our Study Signup page for more information for you or your patients.