The purpose of this study is:
1. To assess the antiviral activity of PRO 140
2. To assess the safety and tolerability of PRO 140
3. To generate additional PK, PD and safety data of PRO 140
1. Males & females, age ≥ 18 years (or minimum adult age as determined by local
2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
3. CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250
4. Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
7. Women of reproductive potential must have a negative serum pregnancy test at Late
Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of
study medication, & be non-lactating. Male & female subjects must agree not to
participate in a conception process from Early Screening Visit through Day 59.
1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™
2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant
during the study.
3. History of active hepatitis within the previous 24 wks
4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, including
PRO 140, experimental or approved.
5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to
administration of study drug.
Stephen Morris, MD, PhD
Progenics Pharmaceuticals, Inc.