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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002246

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS Dementia Complex HIV Infections	Drug: Stavudine	Phase 3

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex

Study Start Date :

Oct 1, 1997

Actual Primary Completion Date :

Mar 1, 1999

Actual Study Completion Date :

Mar 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HIV Neurobehavioral Research Ctr	San Diego	California	United States	92103
2	AIDS ReSEARCH Alliance	West Hollywood	California	United States	90069
3	Mount Sinai Hosp	New York	New York	United States	100296574
4	National Centre in HIV Epidemiology and Clinical Research	Sydney		Australia
5	Charing Cross and Westminster Med School	London SW 10		United Kingdom