Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Advanced Peptides
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.