Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01969058
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2013-08-21
Brief Title:
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4 T Cell Recovery
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
A Prospective Randomized Controlled Study to Evaluate the Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4 T Cell Recovery on Suppressive Antiretroviral Therapy ART
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin a drug that is approved for use in the treatment of severe acne on the immune system The immune system helps the body fight infections When the immune system is not working well one may be at greater risk for diseases that are common in aging like heart disease weaker bones and kidney disease
Detailed Description:
Isotretinoin was administered to participants in the Isotretinoin arm at approximately 05 mgkg PO once daily for 4 weeks then increased to approximately 10 mgkg PO once daily for 12 weeks Follow-up continues to week 28 to evaluate the duration of effect Randomization was stratified by willingness to participate in the gut biopsy substudy A5330s The study population included HIV-1 infected adults whose virus was suppressed on ART excluding women of child bearing potential
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 |
|---|---|---|---|
| UM1AI068636 | NIH | None | httpsreporternihgovquickSearchUM1AI068636 |