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Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia Clinical research trials and Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia. Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia clinical trial. Human subjects often get the best healthcare available for their Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia  Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
For Condition: Cognitive Disorders,HIV Infections
Status: Completed
Sponsor(s): University of Rochester ,
Synopsis: To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on cognitive function, quality of life, and activities of daily living.
Details: Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV seropositivity. - Cognitive impairment. Prior Medication: Allowed: - Prior OPC-14117 other than on the current study. - Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Current opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis). - Severe pre-morbid psychiatric illness including schizophrenia and major depression that would interfere with protocol compliance. - CNS neoplasms. - Any other clinically significant condition or laboratory abnormality that would interfere with ability to participate on study. - Current participation in other drug studies. Patients with the following prior conditions are excluded: - Past history of opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis). - History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease. - History of adverse reaction / allergy to OPC-14117. - Prior participation on this study. Prior Medication: Excluded: - Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).
Total Enrollment: 30
Location and Contact Information:
Columbia Univ
New York City, New York, 10032
United States
Johns Hopkins Hosp
Baltimore, Maryland, 212876965
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: 242A; 02-D94
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002148
Other Hiv Infections Studies:
1. Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452
2. A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
3. A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
4. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
5. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
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