Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
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|ClinicalTrials.gov Identifier: NCT00000392|
Recruitment Status : Completed
First Posted : January 18, 2000
Results First Posted : August 4, 2015
Last Update Posted : February 28, 2017
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 or disease||Intervention/treatment||Phase|
|HIV Infections Cognition Disorders||Drug: Peptide T Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.|
|Study Start Date :||January 1990|
|Actual Primary Completion Date :||August 1996|
|Actual Study Completion Date :||August 1996|
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|