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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT05652478
Phase
PHASE2
Status
Recruiting
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Conditions

  • Healthy Volunteer
  • Integrase Strand Transfer Inhibitors
  • Metabolic Effects
  • Weight Gain

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Dolutegravir (DTG) AND Tenofovir alafenamide (TAF) — DRUG
    50mg dolutegravir (DTG) one tablet AND 25mg tenofovir alafenamide (TAF) one tablet together, orally once daily for 4 wks (Day 14 to Day 42)
  • Tenofovir Disoproxil Fumarate — DRUG
    300mg tenofovir disoproxil fumarate (TDF) one tablet orally once daily for 4 wks (Day 14 to Day 42)
  • Dolutegravir — DRUG
    50mg dolutegravir (DTG) one tablet orally once daily for 4 wks (Day 14 to Day 42)
  • Tenofovir alafenamide — DRUG
    25mg tenofovir alafenamide (TAF) one tablet orally once a day for 4 wks (Day 14 to Day 42)

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Dolutegravir
    50mg one tablet orally once a day for 4 weeks, Day 14 to Day 42
  • Active Comparator: Dolutegravir AND Tenofovir alafenamide
    50mg one tablet orally AND 25mg one tablet orally together once a day for 4 weeks, Day 14 to Day 42
  • Active Comparator: Tenofovir alafenamide
    25mg one tablet orally once a day for 4 weeks, Day 14 to Day 42
  • Active Comparator: Tenofovir Disoproxil Fumarate
    300mg one tablet orally once daily for 4 weeks, Day 14 to Day 42

Primary Outcome Measure

Change in plasma metabolites from ARV initiation to the end of the 4 week period of ARV therapy with each treatment [ Time Frame: Day 14/Wk2 to Day 42/Wk6 of ARV therapy for each of 4 drug regimen. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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