Metabolic Effects of Antiretroviral Drugs in Healthy Adults A Phase 2 Randomized Study

What this Trial Is About

Researchers are investigating how a type of HIV medication called integrase strand transfer inhibitors INSTIs affect weight gain and metabolism in healthy adults. This study aims to understand the changes these drugs may cause in the bodys plasma metabolite profile over a four-week period without the presence of HIV infection. The study is a phase 2 randomized trial involving healthy volunteers aged 18 to 55 years. Participants will be randomly assigned to one of four oral treatment groups Dolutegravir DTG, Tenofovir alafenamide TAF, Dolutegravir plus Tenofovir alafenamide DTG and TAF, or Tenofovir Disoproxil Fumarate TDF. Treatments will be taken once daily for four weeks, starting after a two-week lead-in period without treatment. The study includes initial screening and baseline assessments, followed by treatment and several follow-up visits involving exams, blood tests, body fat and bone density scans, optional fat tissue biopsies, and microbiome sample collections. During the study, participants will have a continuous glucose monitor placed and changed at specific intervals. Researchers will collect various samples and data to analyze metabolic, proteomic, lipidomic, and transcriptomic changes due to the treatments. The primary measurement is the change in plasma metabolites from the start to the end of treatment. Participants will be monitored through baseline, mid-treatment, and post-treatment visits, with the entire participation lasting around six weeks after screening.

Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study