Actively Recruiting
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-14
120
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 through the end of study participation.
You will not qualify if you...
- Current infection with HIV or hepatitis A, B, or C.
- Body mass index (BMI) less than 18.5 kg/m2 or greater than 30.0 kg/m2.
- Weight change greater than 5% in the past 6 months.
- History of or current cardiovascular disease such as congestive heart failure, heart block, or clinically relevant abnormal ECG.
- History of or current liver disease or alanine transaminase serum level greater than 2 times the upper limit of normal.
- History of or current kidney disease or renal insufficiency, or estimated creatinine clearance less than or equal to 80 mL/min.
- Current cancer or history of cancer within 5 years, except localized squamous or basal cell carcinoma.
- History of bariatric surgery.
- Diabetes mellitus or hemoglobin A1c greater than 6.4 percent on screening labs.
- Fasting serum glucose greater than 126 mg/dL.
- History of or current thyroid disorders except minor deviations.
- History of or current asthma or chronic obstructive pulmonary disease.
- Psychological conditions such as clinical depression or bipolar disorder.
- Pregnancy or within 1 year post-partum.
- Breastfeeding.
- Blood pressure greater than 140/90 mm Hg or current antihypertensive therapy.
- Hemoglobin outside acceptable laboratory ranges.
- History of illicit drug, opioid, or alcohol abuse within last 5 years or current use.
- Current use of specific medications or supplements that may interact with study drugs.
- Use of TAF, TDF, and/or FTC for HIV PrEP or research within past 6 months.
- History of exposure to cabotegravir or lenacapavir.
- Current use of medications that may interfere with study measurements.
- History of adverse reactions to study drugs.
- Daily caffeine intake greater than 500 mg.
- Current smoker or tobacco user.
- Recent changes in diet or exercise that could affect study data.
- High-risk sexual activity or unwillingness to use barrier contraception.
- Any other condition or factor that increases risk or interferes with study compliance or results.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Mary E McLaughlin, R.N.
CONTACT
B
Brian P Epling, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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