Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02257788
Status:
WITHDRAWN
Last Update Posted:
2017-03-09
First Post:
2014-10-02
Brief Title:
PRO 140 for Human Immunodeficiency Virus Infection
Sponsor:
Drexel University
Organization:
Drexel University
Study Overview
Official Title:
PRO 140 2103 A Phase 2a Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unlikely to achieve targeted accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PRO 140 2103 is a multicenter randomized parallel group study conducted in male and female adult subjects infected with CCR5-tropic HIV-1
Detailed Description:
Protocol PRO 140 2103 is a multicenter randomized parallel group study conducted in approximately 40 male and female adult subjects n10treatment group infected with CCR5-tropic HIV-1 Subjects will be randomized into one of four treatment groups Blood samples for drug concentrations PD variables and efficacy variables will be obtained over a 59-day period following initiation of dosing Safety will be monitored throughout the course of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01AI095085-03 | NIH | None | httpsreporternihgovquickSearch5U01AI095085-03 |