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

• Status: Unknown status
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Collaborator: Bristol-Myers Squibb
• Treatments: Stavudine

Criteria

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