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New treatment option for Healthy Volunteer
Official title Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
ClinicalTrials.gov ID: NCT05652478
What this study is testing
What is Dolutegravir (DTG) AND Tenofovir alafenamide (TAF)?
Dolutegravir (DTG) AND Tenofovir alafenamide (TAF) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy volunteer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join 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) \ 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...
- History of or current liver disease or alanine transaminase serum level \>2x upper limit of normal.
See the full eligibility 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.
- 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) \ 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 or current asthma or chronic obstructive pulmonary disease.
- Psychological conditions by self-report, such as (but not limited to) clinical depression, 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
- 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
- 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 drug).
- Current use of prescrtiption or nonprescriptive medications that may have interactions with study drugs or confound the study measurements as determined by the investigators.
- History of adverse or allergic reactions to the study drugs.
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.