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
  Purpose

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 Intervention Phase
HIV
Drug: stavudine
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 57
Study Start Date: June 2004
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00235222     History of Changes
Other Study ID Numbers: CREPATS 05-01-PHOENIX
Study First Received: October 6, 2005
Last Updated: October 24, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2014