ClinicalTrials.gg
Sign In
CompletedNCT00002246Updated May 4, 2011

A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

A Phase 3 interventional study of Stavudine in AIDS Dementia Complex and HIV Infections, sponsored by Bristol-Myers Squibb. Completed at 5 sites in 3 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2011-05-04.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Ages
13 Years and older
Sex
All
01

Study summary

The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems involving the brain or spinal cord) in HIV-positive patients.

Read the detailed description

In this open-label, multicenter, multinational study, ZDV is replaced with d4T in ZDV-containing regimens, or d4T is added to non-ZDV-containing regimens in 20 patients experiencing ADC. Patients are defined as having failed treatment if they progress by one ADC stage on the MSK (Memorial Sloan Kettering) rating scale on study (i.e., from Stage 1 to 2 or Stage 2 to 3). Patients are evaluated on a weekly basis until the dementia deterioration is confirmed to be caused by HIV-1. The effect of d4T-containing regimens is assessed for the following parameters: neurological status, survival, AIDS-defining conditions, CSF (cerebrospinal fluid) and plasma viral load, CSF and blood immunological markers, blood CD4 cell counts, and viral resistance. This study also assesses the pharmacokinetics of d4T in the CSF and in the blood.

02

Conditions studied

  • AIDS Dementia Complex
  • HIV Infections

Keywords

  • AIDS Dementia Complex
  • Zidovudine
  • Stavudine
  • Reverse Transcriptase Inhibitors
03

In context

AIDS Dementia Complex

41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 31 interventional studies indexed under AIDS Dementia Complex.

Browse AIDS Dementia Complex studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.

Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

You may be eligible for this study if you:

  • Are -positive.
  • Are at least 13 years old (need consent if under 18).
  • Have AIDS Dementia Complex.
  • Have been on a stable anti-HIV drug regimen for at least 8 weeks prior to study entry.
  • Agree to use effective methods of during the study.
  • Are available for at least 16 weeks of study.

Exclusion criteria

Exclusion Criteria

You will not be eligible for this study if you:

  • Have ever taken d4T.
  • Have a neurological (brain/spinal cord) disease, such as chronic seizures or head injury, or certain other conditions that would interfere with your ability to complete the study.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.
  • Have peripheral neuropathy or a newly diagnosed AIDS-defining infection that requires treatment at the time of study enrollment.
  • Have received certain medications.
  • Cannot take medications by mouth.
  • Have severe diarrhea for at least 7 days in a row within 30 days prior to study entry.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
20 participants

Interventions

06

Study locations

5 sites
  • HIV Neurobehavioral Research Ctr
    San Diego, California 92103, United States
  • AIDS ReSEARCH Alliance
    West Hollywood, California 90069, United States
  • Mount Sinai Hosp
    New York, New York 100296574, United States
  • National Centre in HIV Epidemiology and Clinical Research
    Sydney, Australia
  • Charing Cross and Westminster Med School
    London SW 10, United Kingdom
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 1997, a primary completion of Mar 1999 and a completion of Mar 1999. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 1999
First posted
Aug 31, 2001
Start
Oct 1997
Primary completionActual
Mar 1999
CompletionActual
Mar 1999
Results delay requested
Apr 13, 2011
Last update
May 4, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002246
Lead sponsor
Bristol-Myers Squibb
First posted
Aug 31, 2001
Start date
Oct 1997
Primary completion
Mar 1999
Completion
Mar 1999
Last update
May 4, 2011

Study contacts

B Brew
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 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.

Studies of the drug tested here: Stavudine

Other studies in this condition

AIDS Dementia Complex →

Other studies from this sponsor

Bristol-Myers Squibb →

Start the discussion