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

NCT00002083 | Completed

• 2 other identifiers: 115A01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV Infections; Peripheral Nervous System Disease

Keywords

Peptide T; HIV-1; Administration, Intranasal; Acquired Immunodeficiency Syndrome; Peripheral Nervous System Diseases

Interventions

Peptide T DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:

Sponsors & Collaborators

• Advanced Peptides: lead

Study Sites (4)

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10019, United States

Location

Mount Sinai Med Ctr / Klingenstein Clinical Ctr

New York, New York, 10029, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Related 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)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Peripheral Nervous System Diseases; Acquired Immunodeficiency Syndrome

Interventions

Peptide T

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1993-03

Locations

US (4)