NCT05652478RecruitingPhase 2
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Dec 2022
- Start date
- 24 Sept 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NCT number
- NCT05652478
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 24 Sept 2026 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood pressure \>140/90 mm Hg or current antihypertensive therapy.
- Current use of prescription or nonprescriptive medications that may have interactions with study drugs or confound the study measurements as determined by the investigators.
Other illness
- Current infection with HIV or hepatitis A, B, or C.
- History of or current cardiovascular disease such as congestive heart failure, heart block, or clinically relevant abnormal ECG as determined by investigators.
- 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.
- 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.
- 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).
- Use of TAF, TDF, and/or FTC for the purpose of HIV PrEP or in a research study within the past 6 months.
- Any history of exposure to cabotegravir or lenacapavir (eg, as HIV PrEP or as a participant in a research study for these drugs).
- History of adverse or allergic reactions to the study drugs.
- Any other condition, medication, or dietary pattern that, in the opinion of the investigators, increases risk to the participant, prevents the participant from complying with study procedures, prevents the participant from completing the study, or interferes with the interpretation of study results.
Lab values
- 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).
- 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.
- 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).
- Current use of the following prescription or over-the-counter medications and supplements:
- Carbamazepine
- Oxcarbazepine
- Phenobarbital
- Phenytoin
- Primidone
- Rifabutin
- Rifampin
- Rifapentine
- St. John's wort (Hypericum perforatum)
- Cation-containing antacids or laxatives
- Sucralfate
- Buffered medications
- Oral calcium, iron, magnesium, or zinc supplements, including multivitamins containing these polyvalent cations
- Dalfampridine
- Metformin
- Dofetilide
- Thyroid medications
- Corticosteroids
- Weight loss medications, including prescription drugs (eg, semaglutide and tirzepatide) and over-the-counter diet pills
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Body mass index (BMI) \<18.5 kg/m\^2 or \>30.0 kg/m\^2.
- Weight change \>5% in the past 6 months.
- Pregnancy or within 1 year post-partum.
- Breastfeeding.
- Daily caffeine intake \>500 mg (about 4 cups of coffee).
- Current smoker or user of tobacco products.
- A change in the participant's diet and/or exercise regimen in the past 3 months or during the timeframe of the study period that, in the opinion of the investigator, would compromise the integrity of the data.
- High-risk sexual activity as determined by the investigators, and/or inability or unwillingness to use barrier contraception during the protocol.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.