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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002083
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1993
  Purpose

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


Condition Intervention
HIV Infections
Peripheral Nervous System Disease
Drug: Peptide T

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002083

Locations
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
United States, New York
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019
Mount Sinai Med Ctr / Klingenstein Clinical Ctr
New York, New York, United States, 10029
Sponsors and Collaborators
Advanced Peptides
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002083     History of Changes
Other Study ID Numbers: 115A, 01
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Peptide T
HIV-1
Administration, Intranasal
Acquired Immunodeficiency Syndrome
Peripheral Nervous System Diseases

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Peripheral Nervous System Diseases
Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 19, 2014