Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099645
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-12-17
Brief Title:
Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Placebo-Controlled Phase III Trial of the Anti-HIV Activity and Safety of VGX-410 Mifepristone at Three Dose Levels in HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone also known as VGX-410 and RU486 in HIV infected people
Hypothesis Mifepristone will be generally safe no serious adverse effects and well tolerated
Hypothesis Mifepristone will be generally safe no serious adverse effects and well tolerated
Detailed Description:
Mifepristone is a potent anti-glucocorticoid compound that effectively inhibits replication of both laboratory and clinical HIV isolates in vitro This study will evaluate the anti-HIV activity and safety of 3 different doses of mifepristone in HIV infected people
This study will last approximately 2 months Participants will be randomly assigned to one of 4 study arms and will receive either mifepristone or placebo daily for 28 days Arm A participants will receive one of three doses of placebo Arm B participants will receive 75 mg mifepristone Arm C participants will receive 150 mg mifepristone and Arm D participants will receive 225 mg mifepristone A thorough neck and thyroid examination will be performed within 30 days prior to study entry Blood collection and vital signs measurement will occur at study entry and Days 3 7 14 21 28 and 56 Urine collection and pill counts will also be done at some study visits
This study will last approximately 2 months Participants will be randomly assigned to one of 4 study arms and will receive either mifepristone or placebo daily for 28 days Arm A participants will receive one of three doses of placebo Arm B participants will receive 75 mg mifepristone Arm C participants will receive 150 mg mifepristone and Arm D participants will receive 225 mg mifepristone A thorough neck and thyroid examination will be performed within 30 days prior to study entry Blood collection and vital signs measurement will occur at study entry and Days 3 7 14 21 28 and 56 Urine collection and pill counts will also be done at some study visits
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 |
|---|---|---|---|
| ACTG A5200 | Registry Identifier | DAIDS ES | None |
| 10186 | REGISTRY | None | None |