Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Information source: Groupe Hospitalier Pitie-Salpetriere
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV
Intervention: stavudine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Groupe Hospitalier Pitie-Salpetriere
Official(s) and/or principal investigator(s):
Manuela BONMARCHAND, MD, Study Chair, Affiliation: Service de médecine Interne Hôpital Pitié Salpêtrière
Hocine AIT-MOHAND, MD, Study Chair, Affiliation: Service de Maladies Infectieuses Hôpital Pitié Salpêtrière
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.
Official title: Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients with viral load < 400 copies/ml at week S24
Secondary outcome: 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
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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- 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
Locations and Contacts
Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière, Paris 75013, France
Starting date: June 2004
Ending date: March 2006
Last updated: October 24, 2005