McArthur JC, Yiannoutsos C, Simpson D, Clifford D, Schiffito G, Hollander H, Cohen B, Berger J, Carter KM, Shriver S, Rask C.
J Neurovirol. 1998 Jun 3-6; 4: 359.
Department of Neurology, Johns Hopkins University, Baltimore, MD.
Objective: To evaluate the safety and efficacy of recombinant human nerve growth factor in HIV-associated sensory neuropathy within a multicenter, placebo-controlled, randomized trial (ACTG 291). Background: HIV-associated sensory neuropathy is a prevalent condition in HIV infection, affecting 30% of individuals with AIDS. To date, only symptomatic therapies have been available. Nerve growth factor has the potential to stimulate regeneration of damaged small, unmyelinated nerve fibers. Design/Methods: 270 patients with HIV-associated sensory neuropathy (SN) were enrolled into the study and randomized to received either placebo, 0.1 microgram/kg rhNGF, or 0.3 microgram/kg rhNGF self-administered by subcutaneous injection twice weekly for 18 weeks. Primary outcome measures included changes in self-reported pain (Gracely Pain Scale), prescription analgesic use, quantitative sensory testing (CASE IV device: vibratory and cooling thresholds), neurological examination, and global improvement as assessed by patient and blinded investigator. 60 participants also underwent punch skin biopsies to assess changes in intraepidermal nerve fiber density. Results/Conclusions: Data analysis is underway at present and results from the placebo-controlled, double-blind phase of the study will be presented in June 1998.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Analgesics
- Animals
- Clinical Trials as Topic
- Double-Blind Method
- HIV Infections
- HIV Seropositivity
- Humans
- Nerve Growth Factor
- Neurosciences
- Peripheral Nervous System Diseases
- Sensation Disorders
Other ID:
UI: 102237440
From Meeting Abstracts