Clinical trial NCT00002246: A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
Official title: A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: AIDS Dementia Complex
HIV Infections
Keywords: AIDS Dementia Complex
Zidovudine
Stavudine
Reverse Transcriptase Inhibitors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: HIV Neurobehavioral Research Ctr
state: California
city: West Hollywood
country: United States
facility: AIDS ReSEARCH Alliance
state: California
city: New York
country: United States
facility: Mount Sinai Hosp
state: New York
city: Sydney
country: Australia
facility: National Centre in HIV Epidemiology and Clinical Research
city: London SW 10
country: United Kingdom
facility: Charing Cross and Westminster Med School
Study officials:
name: B Brew
role: STUDY_CHAIR
References: