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

Advanced Peptides

Status: Completed

Conditions: HIV Infections; Peripheral Nervous System Disease

Treatments: Drug: Peptide T

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002083

115A

01

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.