Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344981
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2006-06-23
Brief Title:
Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Study to Probe The Safety And Durability of Tenofovir And a Cell Cycle Agent to Maintain Viral Suppression
Status:
COMPLETED
Status Verified Date:
2021-05
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:
HADIT
Brief Summary:
Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copiesml in volunteers who have achieved viral suppression on a standard HAART regimen
Detailed Description:
This is a 48 week open-label randomized study comparing the safety and durability of a highly active de-intensified therapy TenofovirHydroxyurea to a simplified standard of care therapy Tenofovir plus 3TC or Emtriva plus Sustiva or Nevirapine to maintain a durable viral suppression
Up to 20 subjects with chronic HIV-1 infection suppressed on highly active antiretroviral therapy and without evidence of viral resistance will be enrolled in this study Their present HAART therapy will be stopped
Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qdHydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir The other half will be randomized to Sustiva 600 mg qd or Nevirapine 200 mg twice a day Tenofovir 300 mg qd 3TC 300 mg qd or Emtriva 200 mg once a day Volunteers will continue on this regimen for 48 weeks Patients will be monitored for immunological and virological parameters as well as the incidence of toxicity and side effects during the study If a patients viral load reaches 400 copiesml on 3 consecutive measurements over a 6 week period they will be terminated from the study and started back on their HAART
Up to 20 subjects with chronic HIV-1 infection suppressed on highly active antiretroviral therapy and without evidence of viral resistance will be enrolled in this study Their present HAART therapy will be stopped
Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qdHydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir The other half will be randomized to Sustiva 600 mg qd or Nevirapine 200 mg twice a day Tenofovir 300 mg qd 3TC 300 mg qd or Emtriva 200 mg once a day Volunteers will continue on this regimen for 48 weeks Patients will be monitored for immunological and virological parameters as well as the incidence of toxicity and side effects during the study If a patients viral load reaches 400 copiesml on 3 consecutive measurements over a 6 week period they will be terminated from the study and started back on their 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