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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00000392 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Cognition Disorders |
Drug: Peptide T |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Patients must have:
Allowed:
Exclusion Criteria:
Patients with the following are excluded:
Patients with the following symptoms or conditions are excluded:
Excluded within 4 weeks prior to study entry:
Excluded within 8 weeks prior to study entry:
Long-acting psychoactive agents (e.g., Prozac).
Contacts and Locations| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCSD | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
More Information
| Study ID Numbers: | 90 OD-0013 |
| Study First Received: | January 17, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000392 History of Changes |
| Health Authority: | United States: Federal Government |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex |
|
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome AIDS-Related Complex Immunologic Deficiency Syndromes Cognition Disorders Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
HIV Seropositivity Mental Disorders HIV Infections Sexually Transmitted Diseases Dementia Retroviridae Infections Delirium |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Cognition Disorders Immunologic Deficiency Syndromes |
Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |