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.

Study Overview

• Status: Unknown
• Conditions: HIV
• Intervention / Treatment: Drug: stavudine

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 Type: Interventional
• Enrollment: 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients with viral load < 400 copies/ml at week S24

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Study Completion: March 1, 2006

Study Registration Dates

• First Submitted: October 6, 2005
• First Submitted That Met QC Criteria: October 6, 2005
• First Posted (Estimate): October 10, 2005

Study Record Updates

• Last Update Posted (Estimate): October 25, 2005
• Last Update Submitted That Met QC Criteria: October 24, 2005
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Keywords: Stavudine; Treatment Experienced; Peripheral neuropathy; Viral load; Reduced dose of stavudine
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Stavudine
• Other Study ID Numbers: CREPATS 05-01-PHOENIX