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| Principal Investigator: | Donna Mildvan, MD | |
| Time frame of study: | Ongoing | |
| Time frame of participation: | Up to 28 weeks | |
| Number of participants needed: | Open | |
| Location of Study: | Beth
Israel Medical Center |
|
| Contact Name, Number & Email: | (212)420-4519 or (800) 483-7339 |
Summary:
ACTG
A5157;Using the Amino Acid Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside
(d-drug) Associated Peripheral Neuropathy
A5157 is an open-label, dose-escalation pilot study of acetyl-L-carnitine (ALC) for the treatment of distal symmetric peripheral neuropathy (DSPN) associated with dideoxynucleosides (e.g., d4T, ddC, ddI) in HIV-infected subjects.
Study Design:
Day 1 – Day 7:
· ALC 500 mg BID
Day 8 – Day 14:
· ALC 1000 mg BID
Day 15 – Week 24:
· ALC 1500 mg, or maximum tolerated dose, BID
Pain scale assessments and safety information will be obtained every 6
weeks. An intraepidermal nerve-fiber and subcutaneous adipose tissue biopsy
will be obtained at baseline and 24 weeks.
Criteria for Participation:
- HIV-1 RNA < 10,000 copies/mL
- Stable antiretroviral medication regimen containing at least one dideoxynucleoside analogue (d-drug) for > 8 weeks
- Evidence of sensory neuropathy, as determined by a neurologist
Compensation:
$20 per visit upon entry into the study, and at every regularly scheduled clinic visit thereafter. $30 for each of two skin biopsies.