Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
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.
|HIV Infections Cognition Disorders||Drug: Peptide T Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
|Official Title:||Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.|
- Change in Global Neurocognitive Performance z Score From Baseline [ Time Frame: Baseline and 6 months ]Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
- Change in Neurocognitive Performance Domain z Scores From Baseline [ Time Frame: Baseline and 6 months ]Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
|Study Start Date:||January 1990|
|Study Completion Date:||August 1996|
|Primary Completion Date:||August 1996 (Final data collection date for primary outcome measure)|
Active Comparator: Peptide T
Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months
|Drug: Peptide T|
Placebo Comparator: Placebo
Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000392
|United States, California|
|Los Angeles County - USC Med Ctr|
|Los Angeles, California, United States, 90033|
|San Diego, California, United States, 92103|
|United States, Florida|
|Univ of Miami School of Medicine|
|Miami, Florida, United States, 33136|