HIV drug weight gain mystery: healthy volunteers sought for clues

NCT ID NCT05652478

Recruiting now Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 34 times

Summary

This study tests four different HIV drug regimens in 120 healthy volunteers to see how they affect metabolism and weight. Participants take one of the drugs or a combination for four weeks, with blood tests, body scans, and optional fat biopsies. The goal is to understand why some HIV drugs cause weight gain, which could lead to better treatments for people with HIV.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Dolutegravir and Tenofovir alafenamide (HIV drugs)
What this could lead to: If successful, this study could help explain why some HIV drugs cause weight gain, leading to safer treatments for people with HIV.
What could go wrong: This is an early phase 2 study in healthy volunteers, not people with HIV, so results may not directly apply. The study is small and short-term, so long-term effects remain unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

metabolic disease Weight Gain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY VOLUNTEER INTEGRASE STRAND TRANSFER INHIBITORS METABOLIC EFFECTS WEIGHT GAIN

Contacts and locations

Locations

National Institutes of Health Clinical Center
RECRUITING

Bethesda, Maryland, 20892, United States

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