Status:
COMPLETED
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. Subjects will be rando...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00114699
Start Date
April 1 2005
End Date
April 1 2006
Last Update
August 2 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
AIDS Research Alliance
Los Angeles, California, United States
2
Quest Clinical Research
San Francisco, California, United States
3
Fort Lauderdale, Florida, United States
4
The Orlando Immunology Center
Orlando, Florida, United States