Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
NCT00235222 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2005-10-25
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.
Conditions
Interventions
- DRUG
-
stavudine
Sponsors & Collaborators
- collaborator INDUSTRY
-
Groupe Hospitalier Pitie-Salpetriere
lead OTHER
Principal Investigators
-
Manuela BONMARCHAND, MD · Service de médecine Interne Hôpital Pitié Salpêtrière
-
Hocine AIT-MOHAND, MD · Service de Maladies Infectieuses Hôpital Pitié Salpêtrière
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Completion
- 2006-03-31
Countries
- France
Study Locations
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