Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
Status:
Completed
Trial end date:
1994-06-01
Target enrollment:
Participant gender:
Summary
PRIMARY: To assess the safety of nimodipine in the treatment of HIV-Associated Motor /
Cognitive Complex (formerly AIDS dementia complex). To assess the systemic or central nervous
system toxicities (e.g., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle
pain or cramp, acne) of nimodipine.
SECONDARY: To assess the efficacy of nimodipine in stabilizing the progression of
HIV-Associated Motor / Cognitive Complex by improvement in neuropsychological test
performance, peripheral neuropathy, or other neurologic manifestations.
HIV-infected patients may develop a condition known as HIV-Associated Motor / Cognitive
Complex (also known as AIDS dementia complex) that causes damage to the nervous system,
particularly the brain and spinal cord. Evidence exists that nimodipine protects nerve cells
in culture from injury by HIV. Although nimodipine has been used in patients with other
neurological problems, its safety and effectiveness in halting the progression of
HIV-Associated Motor / Cognitive Complex is not yet known.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)