Safety and efficacy of thymopentin in zidovudine (AZT)-treated asymptomatic HIV-infected subjects with 200-500 CD4 cells/mm3: a double-blind placebo-controlled trial

What Was Tested

The paper reports a study of Thymopentin, published as a randomized controlled trial.

The 352 subjects were prestratified by prior AZT use into stratum I (235 subjects, > 6 months AZT at entry) and stratum II (117 subjects, < or = 6 months AZT at entry).

Who Took Part

The study group was 352 subjects.

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

How the Study Was Run

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

The subjects were allocated by chance, so the Thymopentin group and the comparison group should start out alike.

As a double-blind Thymopentin study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Thymopentin could be set against what happens without it.

Clinical end points, CD4 cell counts, serum p24, serum immune complex dissociated (ICD) p24, and safety variables were evaluated through 48 weeks, using an intent-to-treat analysis.

What Was Measured

The subject headings attached to it are CD4 Lymphocyte Count, Disease Progression, Drug Resistance, Microbial, HIV, HIV Core Protein p24, HIV Infections and Patient Compliance.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Thymopentin in 352 subjects.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 1995 (Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association), a journal based in United States.

More context: the Thymopentin compound page, all human trials.