Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006209
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs
Sponsor:
Aaron Diamond AIDS Research Center
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Open-Label Dose Escalation Trial of Tucaresol in HIV-1 Infected Subjects Taking Potent Antiretroviral Therapy
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 see if it is safe to give tucaresol to HIV-infected patients who are taking combination anti-HIV therapy HAART This study also examines the effect tucaresol has on viral load level of HIV in the body when tucaresol is used with HAART
Detailed Description:
Patients are enrolled sequentially into the next available dosage cohort Each cohort receives a single dose of tucaresol is observed for 2 weeks and then receives 3 alternate-day doses of drug and careful safety monitoring including 4 weeks follow-up after the final dose Dose cohorts receive drug sequentially the lowest-dose cohort receiving the drug first Dose escalation may not proceed to the next higher-dose cohort until all patients from the prior lower-dose cohort have completed the 4-week follow-up after the multiple dosing adverse events are within the described bounds and the FDA has reviewed the safety information from the treated cohort and approved the dose escalation The drug is administered 4 times within the 8 weeks of the study period Weekly visits are required Patients receive financial compensation
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: