CClinicalTrials.gg
Sign In
CompletedNCT00002308Updated Aug 5, 2011

A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

An interventional study of Stavudine in HIV Infections, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2011-08-05.

Sponsored by Bristol-Myers Squibb · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.

02

Conditions studied

  • HIV Infections

Keywords

  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Stavudine
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • HIV positivity with CD4 count \< 300 cells/mm3.
  • Intolerance to or failure on approved antiretroviral therapy.
  • Ability to provide informed consent (of parent or guardian if appropriate).

NOTE:

  • Incarcerated persons may be eligible to participate.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Grade 2 or worse disease-related peripheral neuropathy.
  • Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
  • Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
  • Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).

Strongly discouraged:

  • AZT, ddI, ddC, and other antiretroviral agents.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double

Interventions

  • DrugStavudine
06

Study locations

1 site
  • Bristol - Myers Squibb Co
    Princeton, New Jersey 085434500, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002308
Lead sponsor
Bristol-Myers Squibb
First posted
Aug 31, 2001
Completion
Nov 1991
Last update
Aug 5, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Bristol-Myers Squibb

Start the discussion