A Study to Evaluate the Use of Stavudine (d4T) to Treat A... | NCT00002246

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

NCT00002246

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 4, 2011Estimated

Enrollment

Phase

Phase 3

Conditions

AIDS Dementia Complex
HIV Infections

Interventions

Stavudine

Countries

United States
Australia
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AI455-064

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 1997

Primary Completion Date

Mar 1999Actual

Completion Date

Mar 1999Actual

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 13, 2011

Certification/Extension First Submitted that Passed QC Review

Apr 13, 2011

Certification/Extension First Posted Date

Apr 25, 2011Estimated

Last Update Submitted Date

Apr 28, 2011

Last Update Posted Date

May 4, 2011Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Stavudine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-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 birth control during the study.
Are available for at least 16 weeks of study.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
B Brew		Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
HIV Neurobehavioral Research Ctr		San Diego	California	92103	United States
AIDS ReSEARCH Alliance

Condition Browse Module

MeSH Terms

ID	Term
D015526	AIDS Dementia Complex
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018119	Stavudine

Ancestor Terms

ID	Term
D013936	Thymidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided