PRO 140 for Human Immunodeficiency Virus

Inclusion Criteria

• •1. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
• •2. Males and females, age ≥ 18 years
• •3. Screening plasma HIV-1 RNA \> 1,000 copies/mL confirmed by second test while on the current antiretroviral regimen
• •4. History of non-prescription injection and/or non-injection recreational drug use
• •5. CD4 lymphocyte cell counts \> 100 cells/mm3
• •6. Clinically normal resting 12-lead ECG at screening visit
• •7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through week 24.
• •8. Non-adherent, history of poor adherence to a previous antiretroviral regimen.