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Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. Clinical research trials and Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.. Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. clinical trial. Subjects often receive the most expert healthcare possible for their Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.  Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
For Condition: HIV Infections,Cognition Disorders
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals. Previous studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients. Patients are randomized to receive either peptide T or placebo for the first 6 months. All patients then receive open-label peptide T for approximately 6 additional months. Neuropsychologic tests are used to determine drug effects.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have: 1. Cognitive dysfunction on neuropsychological testing. 2. HIV antibody positivity. 3. Expected survival of 6 months. 4. EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC. 5. Medically stable EKG and urinalysis. 6. Given informed, written consent to participate. - Allowed: 1. Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir. 2. Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressant for relief of peripheral neuropathy that is expected to remain unchanged throughout the first 6 months of the study. - Abstinence or agree to use barrier methods of birth control / contraception during the study - Negative pregnancy test within 30 days of study entry - Bilirubin <= 3 - CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-related symptoms. CD4 count > 500 cells/mm3 allowed if patient has other (non-cognitive) HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.) - Creatinine <= 1.5 mg/dl - Granulocytes >= 750 - Hemoglobin > 8 g/dl (No more than two transfusions per month permitted.) - Other Lab Values Prothrombin time > 70 percent of control. - Platelet Count >= 75000 /mm3 - SGOT(AST) < 5 x ULN (ULN = upper limit of normal). Exclusion Criteria: - Patients with the following are excluded: 1. History of mental retardation or learning disability. 2. Evidence of current DSM-III-R Axis I disorder within 3 months prior to study entry or past history of psychotic disorder or bipolar mania. 3. History of neurologic disorder not secondary to HIV infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder). - Patients with the following symptoms or conditions are excluded: 1. Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study. 2. Serious underlying medical problems that may complicate interpretation of the treatment results, including unstable diabetes mellitus, severe arteriosclerotic heart disease, uncontrolled hypertension, or hepatic or renal failure. 3. Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results. 4. Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration. - Excluded within 4 weeks prior to study entry: 1. Antiretrovirals except as allowed in the Patient Inclusion Criteria. 2. Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics, amphetamines) Excluded within 8 weeks prior to study entry: Long-acting psychoactive agents (e.g., Prozac). - Active alcohol abuse in the past 3 months, or abuse judged by the investigators as likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine, marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines or other substances within the past 3 months, judged by the investigators as likely to interfere with the analyses of neuropsychologic tests. - Positive pregnancy test within 30 days of study entry - No abstinence or no agreement to use barrier methods of birth control / contraception during the study
Total Enrollment:
Location and Contact Information:
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UCSD
San Diego, California, 92103
United States
Additional Information:
Study ID Numbers: 90 OD-0013;
Study Start Date:
Record last reviewed: December 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000392
Other Cognition Disorders Studies:
1. Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
2. A Study of Saquinavir Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients
3. A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects
4. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination with QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults
5. A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
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Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
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