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Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients 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 Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients Clinical research trials and Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients 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 Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients. Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients 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 Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients 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.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients  Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
For Condition: HIV Infections,Cognition Disorders
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Neurological Disorders and Stroke (NINDS),Neurologic AIDS Research Consortium (NARC)
Synopsis: The purpose of this study is to evaluate the use of selegiline transdermal system (STS) in the treatment of decreased mental function in patients with HIV. A decrease in mental function often occurs in patients with HIV. Antiretroviral drugs are used to treat this but are not entirely effective. Some other therapy could play a role. The drug selegiline, in a pill form, is used to treat Parkinson's disease, a serious brain disorder. It is believed this drug might protect the brain and repair some damage. This study will use this drug in a "patch" form, which has not been approved by FDA, to see if it helps with decreased mental function in patients with HIV.
Details: Cognitive impairment is a common sequela of HIV infection that can progress to dementia. Antiretroviral agents are the only current therapy, but treatment response is frequently unsatisfactory, short lived, or the agents are poorly tolerated in doses adequate for central nervous system penetration. An adjunctive therapy that interferes with the cascade of events triggered by the virus is likely to play an important role. Oral selegiline is an approved and marketed drug for the symptomatic treatment of Parkinson's disease. Studies suggest that selegiline has a neuroprotective effect and that it may exert a "rescue effect" on dying and injured neurons. This study proposes to use transdermal selegiline, which may deliver a greater dose level than oral administration, in the treatment of HIV-associated cognitive impairment. This is a two step study, with each step lasting 24 weeks. Step 1 is double-blind and Step 2 is open label. At entry, patients are randomized to one of three arms. Arm 1 receives a lower-dose STS, Arm 2 receives a higher-dose STS, and Arm 3 receives a placebo. One STS patch will be applied daily at the same time for 24 weeks. Patients are evaluated at the clinic at entry and at Weeks 2, 4, 8, 12, 16, and 24. Cognitive status will be evaluated by performance on a series of neuropsychological assessments. Patients who complete Step 1 may participate in Step 2 and receive the same or a safer or more effective dose as determined in Step 1. Patients on placebo in Step 1 receive active STS treatment. The STS patch is applied once daily for an additional 24 weeks and patients are evaluated at the clinic at Weeks 28, 36, and 48.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV positive - Stable anti-HIV therapy or no anti-HIV therapy for at least 8 weeks prior to study screening - AIDS Dementia Complex Stage > 0 - Decreased mental function as shown by tests during screening - IQ >= 70 - Acceptable methods of contraception during study and for 3 months following study Exclusion Criteria - Tumor other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma, that does not involve a large organ or which does not require chemotherapy - Serious mental illness that, in the opinion of the doctor, might interfere with the study - Reserpine or meperidine use within 7 days prior to study entry - Nefazodone within 14 days prior to study entry - Monoamine oxidase inhibitor, including selegiline, within 30 days prior to study entry - Sympathomimetic medications, including over the counter diet and cold (oral or nasal) remedies, within 14 days of study entry - Decreased blood pressure when standing up - Uncontrolled high blood pressure - AIDS-related infection within 30 days prior to study entry - Over-the-counter (OTC) diet or cold drugs within 14 days before study entry - Nervous system disorders such as multiple sclerosis, stroke, serious head injury, uncontrolled epilepsy, Tourette's syndrome, Huntington's disease, dementias due to alcohol abuse, vitamin B12 deficiency, syphilis, etc. - Infections or tumors of the central nervous system - Any other condition that, in the investigator's opinion, would interfere with the study - Certain investigational drugs within 30 days before study entry - Pregnant or breast-feeding - Allergic to selegiline or the STS patch
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
GiovanniSchifitto, Study Chair,
Univ of California San Francisco *No longer recruiting*
San Francisco, California, 94110
United States
No longer recruiting
Stanford Univ *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
SUNY / Erie County Med Ctr at Buffalo *No longer recruiting*
Buffalo, New York, 14215
United States
No longer recruiting
UCLA CARE Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
Willow Clinic *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Harvard (Massachusetts Gen Hosp) *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Teri Flynn 617-726-3819
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
Rhode Island Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
The Miriam Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Univ of Southern California *Recruiting*
Los Angeles, California, 90033-1079
United States
Recruiting Luis Mendez 323-343-8283
Stanley Street Treatment and Resource *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Univ of Texas, Southwestern Med Ctr *Recruiting*
Dallas, Texas, 75235-9173
United States
Recruiting Chip Lohner 214-590-0414
Cook County Hospital Core Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
The CORE Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Mykyelle Crawford 212-305-2665
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Cheryl Marcus 919-843-8761
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
San Mateo County AIDS Program *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Additional Information:
Study ID Numbers: ACTG A5090; AACTG A5090
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013585
Other Hiv Infections Studies:
1. A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
2. Safety and Effectiveness of a Four-Drug Combination Treatment in HIV-infected Subjects Failing Therapy with Antiretroviral Regimens
3. A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
4. Phase I Safety Study of anti-HIV Immune Serum Globulin (Human)
5. Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
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Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
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