RECRUITING

Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers

Conditions

Healthy Volunteer Weight Gain Metabolic Effects Integrase Strand Transfer Inhibitors Metabolism HIV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF). Eligibility: Healthy people aged 18 to 55. Design: Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function. Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between. Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay. Participants will have tests to see how their body uses energy: They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times. They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density. They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass. They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.

Official Title

A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers

Quick Facts

Study Start:2024-12-09

Study Completion:2030-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05652478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 18 to 55 years. * Able to provide informed consent. * Willing and able to stay in the whole-room indirect calorimetry suite on 6 occasions. * Willing to reside on the metabolic unit in the Clinical Center for 2 stays of 11 consecutive days over the course of 5 weeks. * Willing to allow samples and data to be stored and shared for future research.	* 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 or a trained athlete. * 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 \<=50 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. * 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. * History of or current glaucoma. * Psychological conditions by self-report, such as (but not limited to) claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study. * Pregnancy or within 1 year post-partum. * Experiences irregular menstrual cycles. * Breastfeeding. * Blood pressure \>140/90 mm Hg or current antihypertensive therapy. * Anemia, defined as hemoglobin \<13 g/dL (males) or \<12 g/dL (females). * History of illicit drug, opioids, 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 medications/dietary supplements/alternative therapies known to alter energy metabolism. * Current use of prescription medications, including recent use (6 months) of Descovy or Truvada (eg, for purposes of PrEP). * Any history of exposure to cabotegravir (eg, as participant in research study for this drug). * Current use of nonprescriptive medications that may have interactions with study drugs 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. * Participants with dietary allergies, intolerances, or eating patterns that would preclude them from consuming controlled metabolic meals. * Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Inclusion Criteria

Exclusion Criteria

* Aged 18 to 55 years.
* Able to provide informed consent.
* Willing and able to stay in the whole-room indirect calorimetry suite on 6 occasions.
* Willing to reside on the metabolic unit in the Clinical Center for 2 stays of 11 consecutive days over the course of 5 weeks.
* Willing to allow samples and data to be stored and shared for future research.

* 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 or a trained athlete.
* 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 \<=50 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.
* 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.
* History of or current glaucoma.
* Psychological conditions by self-report, such as (but not limited to) claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study.
* Pregnancy or within 1 year post-partum.
* Experiences irregular menstrual cycles.
* Breastfeeding.
* Blood pressure \>140/90 mm Hg or current antihypertensive therapy.
* Anemia, defined as hemoglobin \<13 g/dL (males) or \<12 g/dL (females).
* History of illicit drug, opioids, 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 medications/dietary supplements/alternative therapies known to alter energy metabolism.
* Current use of prescription medications, including recent use (6 months) of Descovy or Truvada (eg, for purposes of PrEP).
* Any history of exposure to cabotegravir (eg, as participant in research study for this drug).
* Current use of nonprescriptive medications that may have interactions with study drugs 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.
* Participants with dietary allergies, intolerances, or eating patterns that would preclude them from consuming controlled metabolic meals.
* Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Contacts and Locations

Study Contact

Mary McLaughlin, R.N.

CONTACT

(301) 435-8001

mm149t@nih.gov

Janaki C Kuruppu, M.D.

CONTACT

(301) 496-9320

janaki.kuruppu@nih.gov

Principal Investigator

Janaki C Kuruppu, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Janaki C Kuruppu, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09

Study Completion Date2030-01-31

Study Record Updates

Study Start Date2024-12-09

Study Completion Date2030-01-31

Terms related to this study

Keywords Provided by Researchers

Metabolism
HIV
Integrase Strand Transfer Inhibitors

Additional Relevant MeSH Terms

Healthy Volunteer
Weight Gain
Metabolic Effects
Integrase Strand Transfer Inhibitors