Peptide T in the treatment of painful distal neuropathy associated with AIDS: results of a placebo-controlled trial. The Peptide T Neuropathy Study Group.
OBJECTIVE
To assess the safety and efficacy of Peptide T in the treatment of painful distal symmetrical polyneuropathy (DSP) associated with human immunodeficiency virus (HIV) infection.


BACKGROUND
Painful DSP is a frequent complication of HIV infection, although its etiology and optimal treatment are unknown. Peptide T (D-(alpha 1)-Peptide T-amide) has been found in phase I trials and anecdotal reports to relieve neuropathic pain in AIDS patients.


METHODS
In this multicentered, double-blind, randomized study, subjects received intranasal Peptide T 6 mg/day or placebo for 12 weeks. The primary outcome measure was change in the modified Gracely pain score. Secondary efficacy variables were results of neurologic examination, neuropsychological and electrophysiologic studies, global evaluation, and CD4 lymphocyte counts.


RESULTS
Of 81 evaluable subjects, 40 received Peptide T and 41 received placebo. The change in pain scores was not significantly different (p = 0.32) in the Peptide T group (-0.24) as compared to placebo (-0.39). Group comparisons were not significantly different for change in any clinical examination or neuropsychologic measure, sural nerve amplitude or conduction velocity, or CD4 lymphocyte count. No significant drug-related adverse effects occurred in either group.


CONCLUSIONS
Intranasal Peptide T is safe but ineffective in the treatment of painful DSP associated with AIDS.
Simpson
D M
DM
Department of Neurology, Mount Sinai Medical Center, New York, NY 10029, USA.
Dorfman
D
D
Olney
R K
RK
McKinley
G
G
Dobkin
J
J
So
Y
Y
Berger
J
J
Ferdon
M B
MB
Friedman
B
B
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D015717:Peptide T / Q000627:therapeutic use*; D011115:Polyneuropathies / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
D015717:Peptide T