Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235222
Status:
UNKNOWN
Last Update Posted:
2005-10-25
First Post:
2005-10-06
Brief Title:
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine d4T THE PHOENIX STUDY
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Organization:
Groupe Hospitalier Pitie-Salpetriere
Study Overview
Official Title:
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine d4T THE PHOENIX STUDY
Status:
UNKNOWN
Status Verified Date:
2005-10
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:
Lipodystrophie peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of stavudine 30 mg bid in HIV patients with controlled viral load and body weight 60 kg receiving an antiretroviral therapy containing stavudine 40 mg bid
Detailed Description:
Stavudine is a nucleoside inhibitor larged used in HIV treatments and has been associated to mithocondrial toxicity As it is still largely used in developping countriesthe evaluation of reducing dose is of importance
A single-arm open pilot 48 weeks study to evaluate the capacity of a switch from d4T 40 mg to 30 mg bid in patients with body weight 60kg to maintain full viral load suppression Clinical and biological evaluations were carried out at baseline W24 and W48 Primary end-point is viral load suppression 400 coiesml at W24
Secondary end-points are Evolution of CD4 count at W24 and W48 neurological examination at Baseline W24 and W48 metabolic parameters and stavudine PK at W24
A single-arm open pilot 48 weeks study to evaluate the capacity of a switch from d4T 40 mg to 30 mg bid in patients with body weight 60kg to maintain full viral load suppression Clinical and biological evaluations were carried out at baseline W24 and W48 Primary end-point is viral load suppression 400 coiesml at W24
Secondary end-points are Evolution of CD4 count at W24 and W48 neurological examination at Baseline W24 and W48 metabolic parameters and stavudine PK at W24
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