Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study (NCT05652478) | Clinical Trial Compass
RecruitingPhase 2
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
United States120 participantsStarted 2026-07-01
Plain-language 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. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will be randomized to one of four oral treatments: Tenofovir Disoproxil Fumarate TDF/Viread, Tenovovir Alafenamide TAF/Vemlidy, Dolutegravir DTG/Tivicay, or both TAF and DTG taken together for 4 weeks.
Participants will have a Day 0 visit for the Lead-In Baseline visit for an exam and blood tests and continuous glucose monitor placement.
Participants will return in 2wks or Day 14/Wk 2 for a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density. Optional adiopse (fat) tissue biopsy in the abdomen, and optional microbiome specimen collections. Continuous glucose monitor changed. Oral once a day dose medication will be started with education.
Participants will return in 2wks or Day 28/Wk 4 for exam, labs, and continuous glucose monitor changed.
Participants will return in 2wks or Day 42/Wk 6 for final exam, labs, repeat DEXA scan, repeat adipose tissue biopsy, and microbiome specimen collections.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Aged 18 to 55 years.
* Able to provide informed consent.
* Willing to allow samples and data to be stored and shared for future research.
* Agrees to use a barrier method of contraception or abstain from sexual activity starting at screening though the end of study participation.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Current infection with HIV or hepatitis A, B, or C.
* Body mass index (BMI) \<18.5 kg/m\^2 or \>30.0 kg/m\^2.
* Weight change \>5% in the past 6 months.
* History of or current cardiovascular disease such as congestive heart failure, heart block, or clinically relevant abnormal ECG as determined by investigators.
* History of or current liver disease or alanine transaminase serum level \>2x upper limit of normal.
* History of or current kidney disease or renal insufficiency, or estimated creatinine clearance \<=80 mL/min (Modification of Diet in Renal Disease equation).
* Current cancer or history of cancer within 5 years of screening, with the exception of squamous cell carcinoma or basal cell carcinoma that is localized and does not require systemic therapy.
* History of bariatric surgery.
* Diabetes mellitus as defined by a prior diagnosis or a hemoglobin A1c of \>6.4 percent on screening labs.
* Fasting serum glucose \>126 mg/dL.
* Hist…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is enrolling healthy volunteers and giving them antiretroviral drugs for 4 weeks even though they don't have HIV — what would be the actual risk to me of taking these medications without a medical need for them?
2The study is specifically looking at weight gain and metabolic changes caused by integrase strand transfer inhibitors — if I'm already living with HIV and taking one of these drugs, is there a version of this research that would be more relevant to my situation, or would this trial still apply to me?
3Since this is a Phase 2 study, what does that mean for how much is already known about the safety of these ARV drugs in healthy people, and how does that affect whether it's reasonable for someone like me to consider participating?
4The trial measures changes in plasma metabolites over just 4 weeks — is that short window long enough to tell us something meaningful about longer-term metabolic or weight effects, and how should I weigh that limitation when thinking about whether the results would be useful?
5Are there any standard monitoring steps or follow-up plans after the 4-week drug period ends to check whether any metabolic changes reverse or persist, and what support would be available if I experienced side effects?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in plasma metabolites from ARV initiation to the end of the 4 week period of ARV therapy with each treatment
Timeframe: Day 14/Wk2 to Day 42/Wk6 of ARV therapy for each of 4 drug regimen.
Trial details
NCT IDNCT05652478
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)