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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV

Keywords

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Stavudine Reduced dose of stavudine Viral load Peripheral neuropathy Treatment Experienced

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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stavudine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Manuela BONMARCHAND, MD

Role: STUDY_CHAIR

Service de médecine Interne Hôpital Pitié Salpêtrière

Hocine AIT-MOHAND, MD

Role: STUDY_CHAIR

Service de Maladies Infectieuses Hôpital Pitié Salpêtrière

Locations

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Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CREPATS 05-01-PHOENIX

Identifier Type: -

Identifier Source: org_study_id