National Institute of Allergy and Infectious Diseases (NIAID)
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.
A5420 is a phase 2, double-blinded, randomized, placebo-controlled trial of ixazomib in adults with HIV-1 who are virologically suppressed on antiretroviral therapy. Forty-five participants will be randomized 2:1 to ixazomib 4 mg or matching placebo, taken orally once weekly for a total of 25 doses over 24 weeks, while continuing their own suppressive ART. Randomization is stratified by sex (male/female) using permuted blocks to balance enrollment across arms. Participants are evaluated at screening, entry (week 0), and weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24, with a post-treatment eval…
Inclusion Criteria: 1. Documented HIV-1 infection. 2. Plasma HIV-1 RNA of 50 copies/mL or lower, for at least 48 weeks prior to study entry while on antiretroviral therapy. One blip above 50 but below 200 copies/mL in the preceding 48 weeks is permitted provided at least two other measurements in that period were 50 copies/mL or lower. 3. Plasma HIV-1 RNA below the lower limit of quantification within 30 days prior to study entry. 4. Receiving antiretroviral therapy for less than 10 years. 5. On antiretroviral therapy for at least 48 weeks prior to study entry, with no interruption of more th…
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
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