Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
NCT05652478
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
Background: People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes. Objective: To characterize the change in plasma metabolite profile that 4 weeks of each treatment may induce in the absence of HIV infection Eligibility: Healthy people aged 18 to 55. Design: Participants will be screened in the outpatient clinic.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Healthy Volunteer
- Weight Gain
- Metabolic Effects
- Integrase Strand Transfer Inhibitors
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Last updated on ClinicalTrials.gov
- September 29, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Maryland · 1
- National Institutes of Health Clinical Center · Bethesda, MD
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.