Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Naive
Eligibility Criteria
Inclusion Criteria: HIV-1 infection confirmed by enzyme immunoassay (EIA) and Western blot. Age 18 to 64 years. HIV-1 RNA > 5000 copies/mL. CD4+ T cell count > 250 cells/uL. Treatment naïve, or off antiretroviral treatment for at least 30 days prior to screening and 60 days prior to Day 0 CCR5 tropism confirmed by R5 PhenoSense assays. Exclusion Criteria: CXCR4 tropic or dual tropic virus at screening. Laboratory values of Grade 3 or greater according to the Modified Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Tables. History of Category C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition. History of any medical disease or condition that makes the subject (in the opinion of the investigator) unsuitable for the study. Malignancy within the past 5 years (except for basal carcinomas of the skin and in situ cancers of the cervix). Females who are pregnant or breastfeeding, or who plan to become pregnant during the study. Subjects whose dosage or number of prescription medications has changed within 30 days prior to screening Positive for hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV). Positive alcohol or drug screen
Sites / Locations
- AIDS Research Alliance
- Quest Clinical Research
- The Orlando Immunology Center
- Johns Hopkins Hospital
- University Hospitals of Cleveland
- OSU Medical Center