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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002083 on ClinicalTrials.gov Archive Site
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Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS

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

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Interventional
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Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
  • HIV Infections
  • Peripheral Nervous System Disease
Drug: Peptide T
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002083
115A, 01
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Advanced Peptides
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NIH AIDS Clinical Trials Information Service
March 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP