NCT00002083CompletedNot Applicable
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
Advanced Peptides4 sites in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 4
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have:
- •Documented HIV-1 infection.
- •CD4 count < 500 cells/mm
- •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:
- •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:
- •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.
- •Zidovudine (if intolerance not demonstrated).
- •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.
Investigators
Study Sites (4)
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