Randomized double-blind placebo-controlled trial of peptide T for HIV-associated cognitive impairment

What Was Tested

Researchers studied Peptide T in this randomized controlled trial publication.

Cognitive impairment is a common consequence of human immunodeficiency virus (HIV) infection, and dementia is one of the diseases that defines the acquired immunodeficiency syndrome.

Peptide T (d-ala-peptide-T-amide) has been reported to block the binding of gp120 to brain tissue and to protect neurons from the toxic effects of gp120 in vitro.

Who Took Part

By PubMed's age tags, the people studied were teenagers, adults and middle-aged adults, both men and women.

Participants were HIV-seropositive persons with evidence of cognitive deficits on a screening test battery.

Randomization to the 2 study arms was balanced according to several stratification variables, such as CD4+ cell count, severity of cognitive impairment, and antiretroviral therapy at study entry.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and pilot.

Because people in this Peptide T study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Peptide T.

A placebo (an inactive look-alike) gave the Peptide T group a baseline to be compared against.

It is described as a pilot, a small early test of whether a larger Peptide T study would be practical.

Concomitant antiretroviral therapy was allowed.

A comprehensive neuropsychological (NP) battery, which yielded 23 scores, was administered at baseline and the study end point.

The primary outcome measure was a global NP score derived from the 23 standardized scores.

Additional analyses were conducted on subgroups of patients according to the CD4+ count and baseline NP deficit.

What Was Measured

Topics PubMed links to this paper include AIDS Dementia Complex, CD4 Lymphocyte Count, Neuropsychological Tests and Peptide T.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Peptide T.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 1998 (Archives of neurology), a journal based in United States.

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