|
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS Clinical research trials and Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS. Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS  Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
For Condition: HIV Infections,Peripheral Nervous System Disease
Status: Completed
Sponsor(s): Advanced Peptides ,
Synopsis: To compare the effects of intranasal peptide T and placebo in the treatment of painful peripheral neuropathy associated with human immunodeficiency virus (HIV) infection.
Details:
Eligibility:
Study Type: Interventional, Treatment, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Mount Sinai Med Ctr / Klingenstein Clinical Ctr
New York City, New York, 10029
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Additional Information:
Study ID Numbers: 115A; 01
Study Start Date:
Record last reviewed: March 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002083
Other Peripheral Nervous System Disease Studies:
1. An Electronic Pillbox for People With HIV
2. Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
3. The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
4. A Study of Lobucavir in Patients with AIDS
5. Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India
Related Studies:
Other Peripheral Nervous System Disease Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
|
|
|
|
|
|
|
|
