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Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00235222
First received: October 6, 2005
Last updated: October 24, 2005
Last verified: October 2005

October 6, 2005
October 24, 2005
June 2004
Not Provided
Proportion of patients with viral load < 400 copies/ml at week S24
Same as current
Complete list of historical versions of study NCT00235222 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: stavudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
March 2006
Not Provided

Inclusion Criteria:

  • HIV patients
  • Patients with an antiretroviral treatment containing stavudine at standard doses (40mg BID) for at least 3 months
  • Patients with viral load < 400 copies/ml for at least 3 months

Exclusion Criteria:

  • Patients receiving an antiretroviral therapy containing stavudine at 30mg BID
  • Current Opportunistic Infection
  • Current chemotherapy or under cytokines treatment (PEG, INF, IL2)
  • Pregnant or feeding Women
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00235222
CREPATS 05-01-PHOENIX
Not Provided
Not Provided
Groupe Hospitalier Pitie-Salpetriere
Bristol-Myers Squibb
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
Groupe Hospitalier Pitie-Salpetriere
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP