Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
Recruiting
Phase 2
Interventional Study
Healthy Volunteer
Weight Gain
Metabolic Effects
Integrase Strand Transfer Inhibitors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 120 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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About This Trial
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 pro…
Trial Locations
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Eligibility Criteria
* INCLUSION 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 m…
Contacts