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NCT05652478 · ClinicalTrials.gov registry record · Phase 2
Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers
A Phase 2 study of Healthy Volunteer and Weight Gain, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05652478: Recruiting Phase 2 study of Healthy Volunteer and Weight Gain, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05652478 is a Phase 2 study of Healthy Volunteer and Weight Gain that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 120 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05652478, a Phase 2 study of Healthy Volunteer and Weight Gain, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To determine if TAF or DTG or TDF or DTG/TAF induce changes in plasma metabolites in the 4wks of therapy
Conditions Studied
Interventions
- DRUG Tenofovir alafenamide
- DRUG Dolutegravir
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2030-01-31 |
| Phase | Phase 2 |
What NCT05652478 shows while recruiting
NCT05652478 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (40% lower).
The record links to 4 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Tenofovir alafenamide is the first listed.
NCT05652478 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05652478 about?
NCT05652478 is a clinical study titled "Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers". 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 understa...
What is the current status of trial NCT05652478?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2026-03-26. Estimated completion is 2030-01-31.
What conditions does trial NCT05652478 study?
This clinical trial studies the following conditions: Healthy Volunteer, Weight Gain, Metabolic Effects, Integrase Strand Transfer Inhibitors.
What interventions are being tested in trial NCT05652478?
The interventions under investigation include: Tenofovir alafenamide (DRUG), Dolutegravir (DRUG).
Who is sponsoring clinical trial NCT05652478?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05652478 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05652478's enrollment target sits among peer trials
120 28th of 112 higher than 85 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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