DIA04 UNC HIV IAP086 - Clinical Trial

What is the Purpose of this Study?

Participants will be admitted to the Duke Early Phase Unit for 2 nights, and receive an infusion of either the study drug or placebo. Safety will be monitored for at least 24 hours after the infusion, and there will be numerous blood draws.

What is the Condition Being Studied?

HIV positive and on anti-retroviral therapy for at least 24 months.

Who Can Participate in the Study?

People can join this study if they have HIV and are already taking medicine to control it. They must be generally healthy and not have major health problems affecting the heart, lungs, stomach, kidneys, skin, or liver. They also cannot have had cancer in the past three years.

Age Group
Adults

What is Involved?

This study is testing a new kind of medicine for people with HIV. The medicine is designed to find and target HIV that is hiding quietly inside the body. Researchers want to learn if this new drug is safe and figure out the best dose to use. The goal is to use this medicine along with regular HIV treatments to try to remove all HIV from the body in the future.

Study Details

Full Title
DIA04 IAP086-1: A Phase 1 Single Ascending Dose First-Time in Human Study of the Safety, Tolerability and Pharmacokinetics of IAP086 in Persons with HIV-1 on Antiretroviral Therapy
Principal Investigator
Shruti M. Raja, MD
Neurologist
Protocol Number
IRB: PRO00119783
NCT: NCT07596888
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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