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

Phase 4

• Conditions: HIV

• Registration Number: NCT00235222
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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.

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 Timeline

• Study Start: 2004-06
• Status Verified: 2005-10
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Last Update Submitted: 2005-10-24
• Last Update Posted: 2005-10-25
• Study Completion: 2006-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of patients with viral load < 400 copies/ml at week S24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France