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

Sponsor:	Groupe Hospitalier Pitie-Salpetriere
Collaborator:	Bristol-Myers Squibb
Information provided by:	Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:	NCT00235222

Purpose

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.

Condition	Intervention	Phase
HIV	Drug: stavudine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Stavudine

U.S. FDA Resources

Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:

Proportion of patients with viral load < 400 copies/ml at week S24

Secondary Outcome Measures:

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

Estimated Enrollment:	57
Study Start Date:	June 2004
Estimated Study Completion Date:	March 2006

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235222

Locations

France
Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière
Paris, France, 75013

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere

Bristol-Myers Squibb

Investigators

Study Chair:	Manuela BONMARCHAND, MD	Service de médecine Interne Hôpital Pitié Salpêtrière
Study Chair:	Hocine AIT-MOHAND, MD	Service de Maladies Infectieuses Hôpital Pitié Salpêtrière

More Information

No publications provided

Study ID Numbers:	CREPATS 05-01-PHOENIX
Study First Received:	October 6, 2005
Last Updated:	October 24, 2005
ClinicalTrials.gov Identifier:	NCT00235222 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:

Stavudine
Reduced dose of stavudine
Viral load
Peripheral neuropathy
Treatment Experienced

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Anti-HIV Agents
Stavudine
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010