Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Recruitment status was Active, not recruiting
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 b.i.d.) in HIV patients with controlled viral load and body weight > 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY|
- Proportion of patients with viral load < 400 copies/ml at week S24
- Clinical and biological safety of the reduced doses of stavudine at week 24. Percentage of patients with viral load < 400 copies/ml at week 48, evolution of Cd4 count from baseline to W24 and 48. Evolution of metabolic parameters from baseline to W24 and
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||March 2006|
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 countries,the 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 coies/ml) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235222
|Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière|
|Paris, France, 75013|
|Study Chair:||Manuela BONMARCHAND, MD||Service de médecine Interne Hôpital Pitié Salpêtrière|
|Study Chair:||Hocine AIT-MOHAND, MD||Service de Maladies Infectieuses Hôpital Pitié Salpêtrière|