NCT00235222

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

October 25, 2005

Status Verified

October 1, 2005

First QC Date

October 6, 2005

Last Update Submit

October 24, 2005

Conditions

HIV

Keywords

StavudineReduced dose of stavudineViral loadPeripheral neuropathyTreatment Experienced

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

stavudineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Stavudine

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Manuela BONMARCHAND, MD

    Service de médecine Interne Hôpital Pitié Salpêtrière

    STUDY CHAIR

  • Hocine AIT-MOHAND, MD

    Service de Maladies Infectieuses Hôpital Pitié Salpêtrière

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

June 1, 2004

Study Completion

March 1, 2006

Last Updated

October 25, 2005

Record last verified: 2005-10

Locations

FR(1)