At a glance
ClinicalIndex Comparison Record- ✓Cognitive dysfunction documented on neuropsychological testing
- ✓HIV antibody positive
- ✓Expected survival of at least 6 months
- ✓Either no antiretroviral use in past 4 weeks OR approved use of AZT, ddI, or ddC
- ✕History of mental retardation or learning disability
- ✕Current DSM-III-R Axis I disorder within 3 months prior to study entry, or past history of psychotic disorder or bipolar mania
- ✕History of neurologic disorder not secondary to HIV (e.g., head trauma requiring hospitalization, seizure disorder)
- ✕Kaposi's sarcoma or malignancy likely requiring chemotherapy in first 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
In Brief
A Phase 2 clinical trial evaluating Peptide T and Placebo for HIV Infections and Cognition Disorders. Completed, enrolled 215 participants across 3 sites.
Detailed Summary
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.