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.
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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

Mary E McLaughlin, R.N.

(301) 435-8001

mmclaughli@niaid.nih.gov

CONTACT

Brian P Epling, M.D.

(240) 460-9309

brian.epling@nih.gov

CONTACT