Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS

HIV Infections Clinical Trial

Official title:

Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002083
• Other study ID #: 115A
• Secondary ID: 01
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the effects of intranasal peptide T and placebo in the treatment of painful peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• Documented HIV-1 infection.

• CD4 count < 500 cells/mm3.

• HIV-1-associated distal symmetrical polyneuropathy, with peripheral neuropathy present for at least 6 weeks prior to study entry.

• Pain severity of at least 8 on an analog scale.

• Prior zidovudine therapy for at least the previous 3 months (unless patient has shown intolerance to zidovudine).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Neuropathy due to any other cause besides HIV infection.

• Any symptom consistent with a new or active underlying opportunistic infection or malignancy that could interfere with the evaluation of neuropathy.

• Clinical evidence of new or active CNS disease, potentially from opportunistic infection or neoplasm resulting from HIV infections, that could interfere with the evaluation of neuropathy.

• Other CNS disease (e.g., myelopathy) that could complicate the evaluation of neuropathy.

• Active life-threatening illness other than AIDS.

Concurrent Medication:

Excluded:

• Dapsone.

• Hydralazine.

• Isoniazid (INH).

• Current use of tricyclic antidepressants, anticonvulsants, or clonidine unless the patient has used the drug without a change in dose for at least 3 months prior to study entry.

• Narcotics, unless the patient has been using them for at least 6 weeks prior to study entry.

Prior Medication:

Excluded:

• ddI or ddC in the past 8 weeks.

• Prior peptide T.

• Prior tricyclic antidepressants, anticonvulsants, or clonidine unless they have been used for at least 3 months without change in dose.

• Other investigational drugs within the past 30 days.

Required:

• Zidovudine (if intolerance not demonstrated).

Required:

• Zidovudine for at least the previous 3 months (unless patient has demonstrated intolerance to zidovudine).

Chronic alcohol abuse, or current abuse of psychoactive recreational drugs as defined in DSM IIIR. Patients who may be regarded as unreliable for the study.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Nervous System Diseases
• Peripheral Nervous System Disease
• Peripheral Nervous System Diseases

Intervention

Drug:
• Peptide T

Locations

Country	Name	City	State
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	Mount Sinai Med Ctr / Klingenstein Clinical Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Peptides

Country where clinical trial is conducted

United States, 

References & Publications (1)

MacFadden DK, Doob PR. Role of peptide T in palliation of HIV-1-related painful peripheral neuropathy. Int Conf AIDS. 1991 Jun 16-21;7(2):225 (abstract no WB2173)