Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration: Randomized crossover clinical trial in healthy volunteers

What Was Tested

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

Classical antiretroviral agents may acutely impact on metabolic, mitochondrial, renal and hepatic function in HIV-infected and uninfected persons.

Fusion and integrase inhibitors are supposed to be safer, but have been scarcely investigated.

Who Took Part

PubMed indexes the participants as adults, men only.

Effect of period, treatment, and basal measures were evaluated for each end-point.

How the Study Was Run

The researchers set it up as a randomized and placebo-controlled study.

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

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

Major end-points were changes in lipid profile (total cholesterol, high-density-lipoprotein (HDL)-cholesterol, low-density-lipoprotein (LDL)-cholesterol, triglycerides), insulin resistance (glucose) and mitochondrial toxicity (mitochondrial DNA content-mtDNA-in peripheral blood mononuclear cells).

Renal and hepatic toxicity (creatinine, alanine transaminase (AST), alanine aminotransferase (ALT), bilirubin and total plasma proteins) and overall safety were also analysed.

What Was Measured

To avoid any interference with HIV or other antiretrovirals, the researchers assessed markers of these toxicities in healthy adult volunteers treated with Enfuvirtide (T20) or Raltegravir (RAL).

The subject headings attached to it are Alanine Transaminase, Anti-Retroviral Agents, Creatine, Enfuvirtide, HIV Infections, Healthy Volunteers and Insulin Resistance.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Enfuvirtide.

The abstract goes on to report its results in about 3 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (PloS one), a journal based in United States.

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