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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002246




Registration number
NCT00002246
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
4/05/2011

Titles & IDs
Public title
A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
Scientific title
A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex
Secondary ID [1] 0 0
AI455-064
Secondary ID [2] 0 0
244E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AIDS Dementia Complex 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Stavudine

Treatment: Drugs: Stavudine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/1999
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
National Centre in HIV Epidemiology and Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London SW 10

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002246
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
B Brew
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002246