AEGiS-11IAC: Efficacy of Peptide T in the palliative treatment of neurological HIV-related symptoms.

11th International AIDS Conference


Vancouver, British Columbia — July 7-12, 1996

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Efficacy of Peptide T in the palliative treatment of neurological HIV-related symptoms.

Int Conf AIDS 1996 Jul 7-12; 11:221 (abstract no. Th.B.180)
Garth V, Wolf E, Zander K, v Steinbuechl N, Gorriahn D, Bauer G, Albrecht H, Poppinger J, Jaegel-Guedes E, Jaeger H; KIS, Curatorium for Immunedeficiency, Munchen, Germany. Fax: 0049-89-532 86 51.

Rationale: In an open label pilot phase several patients seemed to profit from treatment with Peptide T. Symptoms like difficulties concentrating, pruritus, nycturia, neuropathy and muscle pain improved in these patients. These clinical impressions had to be validated in a placebo controlled clinical trial.

OBJECTIVES: The primary objective of the study was to evaluate the efficacy of Peptide T in advanced symptomatic HIV patients with an emphasis on health related Quality of Life (QoL) as measured by the MOS-HIV questionnaire. The secondary objective was to examine the efficacy in palliation of neurological HIV related symptoms with an emphasis on neuropsychological performance and painful peripheral neuropathy.

METHODS: The trial had a multicenter, randomized, double blind, placebo controlled design. Patients received subcutaneously either Peptide T 8.5mg/day or placebo for 8 weeks.

RESULTS: 128 of 148 randomized patients were eligible for the primary analysis, 64 in each treatment group. The change in the MOS-HIV total score was not statistically different in the Peptide T group (baseline/week 8 = 50.6 / 55.1), as compared to the placebo group (53.5 / 56.6). The secondary variables showed no statistically significant effect of Peptide T either. Elaborate exploratory analyses showed a statistically significant effect of Peptide T (p=0.044) on one (Trail Making part B) of three neuropsychological complex functional tests in those patients who were otherwise slow for their age with respect to the total time for completing the three tests. A statistically significant tendency (p=0.038) towards an age dependent effect was found in the patients self-evaluation of pain in feet or legs - the older the patient, the less pronounced was the effect. No significant drug related adverse reactions occurred in either group. Discussion/

CONCLUSION: Contrary to previous clinical impressions Peptide T showed no effect on health related QoL, neuropsychological performance or on painful peripheral neuropathy in advanced HIV patients. Positive results of the explorative analyses have to be confirmed by data from other studies.

Keywords: AEGIS, Peptide T, HIV, Palliative Care, Pain, HIV Infections, Peripheral Nervous System Diseases, Pain Measurement, Analgesics, Double-Blind Method, Placebos, Questionnaires, HIV-1, Analgesics, Opioid, Human, ICA11KWDaegis,peptidet,hiv,palliativecare,pain,hivinfections,peripheralnervoussystemdiseases,painmeasurement,analgesics,double-blindmethod,placebos,questionnaires,hiv-1,analgesics,opioid,human,ica11

960707
ThB180

Copyright © 1996 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.