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

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ClinicalTrials.gov Identifier: NCT00235222
Recruitment Status : Unknown
Verified October 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2005
Last Update Posted : October 25, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
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 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.

Condition or disease Intervention/treatment Phase
HIV Drug: stavudine Phase 4

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 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Study Start Date : June 2004
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Stavudine
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients with viral load < 400 copies/ml at week S24

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235222


Locations
France
Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Bristol-Myers Squibb
Investigators
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
More Information

ClinicalTrials.gov Identifier: NCT00235222     History of Changes
Other Study ID Numbers: CREPATS 05-01-PHOENIX
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: October 25, 2005
Last Verified: October 2005

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Stavudine
Reduced dose of stavudine
Viral load
Peripheral neuropathy
Treatment Experienced

Additional relevant MeSH terms:
Stavudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents