Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).
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.
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.
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.