Viewing Study NCT01944371



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Last Modification Date: 2024-10-26 @ 11:12 AM
Study NCT ID: NCT01944371
Status: COMPLETED
Last Update Posted: 2020-05-05
First Post: 2013-09-12

Brief Title: Short-term Disulfiram Administration to Reverse Latent HIV Infection a Dose Escalation Study
Sponsor: University of California San Francisco
Organization: University of California San Francisco

Study Overview

Official Title: Short-term Disulfiram Administration to Reverse Latent HIV Infection a Dose Escalation Study
Status: COMPLETED
Status Verified Date: 2018-12
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 safety pharmacology and bioactivity of disulfiram in antiretroviral treated HIV-infected adults The investigators primary hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in CD4 T-cells in patients on suppressive antiretroviral therapy ART
Detailed Description: Combination antiretroviral therapy for HIV-1 infection can suppress viremia to below the detection limit in the vast majority of motivated individuals with access to these drugs However HIV-1 persists in a small pool of latently infected resting memory CD4 T cells carrying integrated viral genomes Although other reservoirs for HIV-1 exist the general consensus among experts is that latent virus HIV DNA in resting memory CD4 T cells is the primary barrier to HIV-1 eradication A widely discussed approach for eliminating this viral reservoir requires reactivation of latent HIV-1 Disulfiram an FDA-approved drug used to treat alcoholism was shown to activate HIV-1 gene expression in vitro suggesting that activation of latently infected cells in vivo may occur Our primary hypothesis is that the addition of disulfiram to a stable effective antiretroviral drug regimen will result in a dose dependent increase in HIV transcription in CD4 T-cells in HIV-1 in patients on highly active antiretroviral therapy HAART

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
DAIDS-ES ID 11864 OTHER_GRANT None None
K24AI069994 NIH NIAID httpsreporternihgovquickSearchK24AI069994