Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.

What Was Tested

This registered phase 2 trial tested Peptide T.

Patients are randomized to receive either peptide T or placebo for the first 6 months.

It had two arms (groups): Peptide T (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

215 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients must have:. Cognitive dysfunction on neuropsychological testing. HIV antibody positivity. Expected survival of 6 months. EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC.

The full record lists 20 inclusion and 15 exclusion criteria; among the exclusions: patients with the following are excluded:; 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; history of neurologic disorder not secondary to hiv infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Peptide T group and the comparison group should start out alike.

The Peptide T group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Peptide T, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 1990-01 with completion listed for 1996-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Global Neurocognitive Performance z Score From Baseline (time frame: Baseline and 6 months).

It also tracked 1 secondary outcome, for example Change in Neurocognitive Performance Domain z Scores From Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Peptide T in 215 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Peptide T compound page, all human trials.