Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114699
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2005-06-16
Brief Title:
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
Sponsor:
Human Genome Sciences Inc
Organization:
Human Genome Sciences Inc
Study Overview
Official Title:
A Phase 1 Randomized Placebo-Controlled Single-Injection Dose-Escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Ccr5mab004 Human Monoclonal Igg4 Antibody To Ccr5 in Hiv-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 randomly assigned to receive a single intravenous IV infusion of one of four dose levels of CCR5mAb004 or matching placebo A minimum of 10 subjects will be randomized to each cohort at a ratio of 41 activeplacebo A minimum of 40 and maximum of 60 subjects will be enrolled This study will be conducted at up to 10 sites in the United States
Subjects in each cohort will be followed for 56 days after study agent administration The safety tolerability and immunogenicity of CCR5mAb004 will be evaluated based on physical examination adverse event AE reporting and clinical laboratory tests Blood will be collected at specified times for the determination of CCR5mAb004 serum concentrations HIV-1 RNA levels and CD4 and CD8 cell counts If CD4 cell counts are less than 200 during the study period the subject should be offered standard-of-care per HIV treatment guidelines that may include the initiation of appropriate anti-retroviral therapy AVR CCR5mAb004 pharmacokinetic PK and pharmacodynamics PD will be measured over the 56-day study period Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and Day 56
Subjects in each cohort will be followed for 56 days after study agent administration The safety tolerability and immunogenicity of CCR5mAb004 will be evaluated based on physical examination adverse event AE reporting and clinical laboratory tests Blood will be collected at specified times for the determination of CCR5mAb004 serum concentrations HIV-1 RNA levels and CD4 and CD8 cell counts If CD4 cell counts are less than 200 during the study period the subject should be offered standard-of-care per HIV treatment guidelines that may include the initiation of appropriate anti-retroviral therapy AVR CCR5mAb004 pharmacokinetic PK and pharmacodynamics PD will be measured over the 56-day study period Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and Day 56
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None