- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002083
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
June 23, 2005 updated by: Advanced Peptides
To compare the effects of intranasal peptide T and placebo in the treatment of painful peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Univ of Miami School of Medicine
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New York
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New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, United States, 10019
- Saint Luke's - Roosevelt Hosp Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr / Klingenstein Clinical Ctr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 1993
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115A
- 01 (Miami VAHS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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