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

Groupe Hospitalier Pitie-Salpetriere

Status and phase

Unknown

Phase 4

Conditions

HIV

Treatments

Drug: stavudine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00235222

CREPATS 05-01-PHOENIX

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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