Status:
UNKNOWN
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00235222
Start Date
June 1 2004
End Date
March 1 2006
Last Update
October 25 2005
Active Locations (1)
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1
Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière
Paris, France, 75013