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NOT YET RECRUITING
NCT07881809
PHASE2

A Clinical Study of Ixazomib to Reactivate HIV and Reduce HIV Reservoir Size

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This study tests whether a medicine called ixazomib is safe for people living with HIV, and whether it can wake up HIV that is hiding in the body so the immune system and treatment can reach it. HIV can stay hidden inside cells even when antiretroviral therapy (ART) keeps the virus under control. These hidden cells are called the HIV reservoir, and they are the reason HIV is not cured by ART alone. Laboratory research suggests ixazomib may reactivate hidden HIV and also help kill the cells that carry it. Ixazomib is already approved to treat a cancer called multiple myeloma and has been given to a smaller group of people with HIV in an earlier study. About 45 adults with HIV that is well controlled on ART will take part. Participants are assigned by chance to take either ixazomib or a placebo - a capsule with no active medicine - one capsule by mouth once a week for a total of 25 doses. Two out of every three participants receive ixazomib and one out of three receives placebo. Neither participants nor the study staff know which one a participant is taking. Everyone continues their own HIV treatment throughout the study. Participation lasts about 7 months: 24 weeks of weekly capsules and 4 more weeks of follow-up after the last dose. Participants come to the clinic for about 14 visits, and take their capsule 24 to 36 hours before each visit so blood samples can show the effect of the dose. The main purposes of the study are to evaluate whether ixazomib is safe and tolerable, and to measure whether it increases the very small amounts of HIV in the blood compared with placebo. The study also measures the size of the HIV reservoir and how the immune system responds.

Official title: A Phase 2, Double-Blinded, Randomized, Placebo-Controlled Trial of Ixazomib to Reactivate HIV and Reduce HIV Reservoir Size

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-11-23

Completion Date

2027-11-05

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DRUG

Ixazomib 4 mg

One Ixazomib 4 mg capsule should be taken by mouth with a full glass of water on an empty stomach at least 1 hour before or 2 hours after food once a week on the same day and approximately the same time each week

DRUG

Placebo

One Placebo for Ixazomib capsule should be taken by mouth with a full glass of water on an empty stomach at least 1 hour before or 2 hours after food once a week on the same day and approximately the same time each week

Locations (20)

Alabama CRS (Site #31788)

Birmingham, Alabama, United States

University of California, Los Angeles CARE Center CRS (Site #601)

Los Angeles, California, United States

UCSD Antiviral Research Center CRS (Site #701)

San Diego, California, United States

University of California, San Francisco HIV/AIDS CRS (Site #801)

San Francisco, California, United States

University of Colorado Hospital CRS (Site #6101)

Aurora, Colorado, United States

Whitman-Walker Institute, Inc. CRS (Site #31791)

Washington D.C., District of Columbia, United States

The Ponce de Leon Center CRS (Site #5802)

Atlanta, Georgia, United States

Northwestern University CRS (Site #2701)

Chicago, Illinois, United States

Massachusetts General Hospital CRS (MGH CRS) (Site #101)

Boston, Massachusetts, United States

Columbia Physicians & Surgeons (P&S) CRS (Site #30329)

New York, New York, United States

University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site #31787)

Rochester, New York, United States

Chapel Hill CRS (Site #3201)

Chapel Hill, North Carolina, United States

Cincinnati Clinical Research Site (Site #2401)

Cincinnati, Ohio, United States

Case Clinical Research Site (Site #2501)

Cleveland, Ohio, United States

Ohio State University CRS (Site #2301)

Columbus, Ohio, United States

Penn Therapeutics CRS (Site #6201)

Philadelphia, Pennsylvania, United States

University of Pittsburgh CRS (Site #1001)

Pittsburgh, Pennsylvania, United States

Vanderbilt Therapeutics (VT) CRS (Site #3652)

Nashville, Tennessee, United States

Houston Advancing Research Team CRS (Site #31473)

Houston, Texas, United States

University of Washington Positive Research CRS (Site #1401)

Seattle, Washington, United States