Clinical trial NCT00002083: Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
Official title: Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Peripheral Nervous System Disease
Keywords: Peptide T
HIV-1
Administration, Intranasal
Acquired Immunodeficiency Syndrome
Peripheral Nervous System Diseases
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr / Klingenstein Clinical Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
Study officials:
References:
citation: 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)