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

Recruiting now · Phase 2

Conditions studied: Healthy Volunteer, Weight Gain, Metabolic Effects, Integrase Strand Transfer Inhibitors

In brief

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, 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.

Key facts

Study ID

NCT05652478

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Starts

2026-08-13

Expected to finish

2030-01-31

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.
• History of or current hypo- or hyper-thyroid or abnormal TSH, except minor deviations deemed to be of no clinical significance by the investigator.
• History of chronic obstructive pulmonary disease.
• Psychological conditions by self-report, such as (but not limited to) clinical depression, or bipolar disorders, which would be incompatible with safe and successful participation in this study.
• Pregnancy or within 1 year post-partum.
• Breastfeeding.
• Blood pressure >140/90 mm Hg or current antihypertensive therapy.
• Hemoglobin that is either 10 percent below the lower limit or 10 percent above the upper limit of the normal range for the Clinical Center Laboratory (acceptable ranges: females 10.08-17.27 g/dL, males 12.33-19.25 g/dL).
• History of illicit drug, opioid, or alcohol abuse within the last 5 years; current use of illicit drugs or opioids (by history) or excessive alcohol (CAGE assessment score >=2).
• Current use of the following prescription or over-the-counter medications and supplements:
• Carbamazepine
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Primidone

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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