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

10 listopada 2026 zaktualizowane przez: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 evaluation at week 28 following a 4-week washout, for approximately 14 visits over roughly 7 months.

Study treatment is administered as a single 4 mg capsule taken with water on an empty stomach, at least 1 hour before or 2 hours after food, on the same day and at approximately the same time each week. Capsules are not broken, chewed, or opened. Doses preceding a clinic visit are taken 24 to 36 hours before that visit so that plasma and cell-associated virologic measurements capture the post-dose interval.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

45

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35222
        • Alabama CRS (Site #31788)
        • Kontakt:
    • California
      • Los Angeles, California, Stany Zjednoczone, 90035
        • University of California, Los Angeles CARE Center CRS (Site #601)
        • Kontakt:
      • San Diego, California, Stany Zjednoczone, 92103
        • UCSD Antiviral Research Center CRS (Site #701)
        • Kontakt:
      • San Francisco, California, Stany Zjednoczone, 94110
        • University of California, San Francisco HIV/AIDS CRS (Site #801)
        • Kontakt:
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
    • District of Columbia
      • Washington D.C., District of Columbia, Stany Zjednoczone, 20009
        • Whitman-Walker Institute, Inc. CRS (Site #31791)
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30308-2012
        • The Ponce de Leon Center CRS (Site #5802)
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60611
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital CRS (MGH CRS) (Site #101)
        • Kontakt:
    • New York
      • New York, New York, Stany Zjednoczone, 10032
        • Columbia Physicians & Surgeons (P&S) CRS (Site #30329)
        • Kontakt:
      • Rochester, New York, Stany Zjednoczone, 14642
        • University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site #31787)
        • Kontakt:
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7215
        • Chapel Hill CRS (Site #3201)
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45267-0405
        • Cincinnati Clinical Research Site (Site #2401)
        • Kontakt:
      • Cleveland, Ohio, Stany Zjednoczone, 44106
        • Case Clinical Research Site (Site #2501)
        • Kontakt:
          • George Yendewa
          • Numer telefonu: 216-844-2298
          • E-mail: gay7@case.edu
      • Columbus, Ohio, Stany Zjednoczone, 43210-1282
        • Ohio State University CRS (Site #2301)
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • University of Pittsburgh CRS (Site #1001)
        • Kontakt:
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37204
        • Vanderbilt Therapeutics (VT) CRS (Site #3652)
        • Kontakt:
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98104
        • University of Washington Positive Research CRS (Site #1401)
        • Kontakt:
          • Rachel Bender Ignacio
          • Numer telefonu: 206-744-4876
          • E-mail: rbi13@uw.edu

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 than 7 consecutive days in the 90 days prior to entry, and no change in regimen within 90 days prior to entry.
  6. CD4+ T cell count of at least 500 cells/mm^3 within 30 days prior to study entry.
  7. Laboratory values within 30 days prior to study entry: absolute neutrophil count at least 1,000/mm^3; hemoglobin at least 10 g/dL (female participants) or at least 11 g/dL (male participants); platelet count at least 75,000/mm^3; estimated glomerular filtration rate at least 30 mL/min/1.73m^2; bilirubin no more than 1.5 times the upper limit of normal, or no more than 3 times the upper limit of normal if the isolated elevation is attributable to a participant medication or Gilbert syndrome, or direct bilirubin within the normal range.
  8. For participants who can become pregnant, a negative serum or urine pregnancy test within 24 hours prior to study entry.
  9. For participants who can become pregnant, agreement to use two methods of contraception from 10 days prior to study entry through 90 days after the last dose of study treatment. Egg donation is prohibited over the same period.
  10. For participants whose sexual activity could result in a partner becoming pregnant, agreement to use condoms from 10 days prior to study entry through 90 days after the last dose of study treatment. Sperm donation is prohibited over the same period.
  11. Negative hepatitis B surface antigen within 30 days prior to study entry.
  12. Negative hepatitis C antibody, or if positive, a negative HCV RNA PCR, within 30 days prior to study entry.

Exclusion Criteria:

  1. Untreated, active AIDS-defining illness.
  2. Receiving an HIV protease inhibitor or efavirenz as part of the antiretroviral regimen.
  3. Current pregnancy or breastfeeding.
  4. Receipt of an investigational HIV vaccine or HIV-specific monoclonal antibody, or participation in a trial of any investigational product, within 180 days prior to study entry, or expected participation in such a study during this study.
  5. Any current clinically significant acute or chronic medical condition other than HIV infection that in the investigator's opinion would preclude participation.
  6. Any history of peripheral neuropathy, or peripheral neuropathy detected during screening.
  7. History of an HIV-associated malignancy, including Kaposi sarcoma or lymphoma of any type, treated with systemic chemotherapy or immunotherapy.
  8. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 36 months prior to study entry, or for whom such therapy is expected within the following 12 months. Surgical removal of minor localized skin cancers is not exclusionary.
  9. Use of prohibited medications within 30 days prior to study entry or planned use during study participation.
  10. Known allergy, sensitivity, or hypersensitivity to ixazomib or its formulation.
  11. Active drug or alcohol use or dependence that, in the investigator's opinion, would interfere with adherence to study requirements.
  12. Acute or serious illness requiring systemic treatment or hospitalization within 30 days prior to study entry.
  13. Anticipated change in antiretroviral regimen during the 24 weeks following study entry.
  14. Current uncontrolled cardiovascular symptoms, including uncontrolled hypertension (systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg), uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 24 weeks prior to study entry.
  15. Any serious medical or psychiatric illness that in the investigator's opinion could interfere with completion of protocol treatment.
  16. Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of ixazomib, including difficulty swallowing.
  17. Previous treatment with ixazomib.
  18. Known resistance to two or more classes of antiretrovirals.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ixazomib

Ixazomib 4 mg orally once weekly for a total of 25 doses over 24 weeks.
Lek: 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

Inne nazwy:
  • Ninlaro
  • MLN9708
Komparator placebo: Placebo

Placebo for Ixazomib orally once weekly for a total of 25 doses over 24 weeks.
Lek: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Proportion of Ixazomib-Treated Participants With at Least One Grade 3 or Higher Adverse Event Related to Study Treatment.
Ramy czasowe: Entry (Week 0) to Week 28
Entry (Week 0) to Week 28
Frequency of Ixazomib-Treated Participants Who Prematurely Discontinue Study Treatment for Reasons That Are Deemed Related to Study Treatment.
Ramy czasowe: Entry (Week 0) to Week 24
Entry (Week 0) to Week 24
Post-Dose Plasma HIV-1 RNA Levels Measured by Multireplicate Single-Copy Assay (SCA)
Ramy czasowe: Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24
Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Intact Proviral DNA Levels Measured by the Intact Proviral DNA Assay (IPDA)
Ramy czasowe: Screening, Entry (Week 0), and Weeks 4, 24, and 28
Screening, Entry (Week 0), and Weeks 4, 24, and 28
Plasma HIV-1 RNA Levels Measured by Multireplicate Single-Copy Assay (SCA)
Ramy czasowe: Screening, Entry (Week 0), and Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24
Screening, Entry (Week 0), and Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24
Cell-Associated HIV RNA Levels
Ramy czasowe: Screening, Entry (Week 0), and Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24
Screening, Entry (Week 0), and Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24
Cell-Associated HIV RNA/DNA Ratio
Ramy czasowe: Screening, Entry (Week 0), and Weeks 4, 24, and 28
Screening, Entry (Week 0), and Weeks 4, 24, and 28

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Współpracownicy

Takeda

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

23 listopada 2026

Zakończenie podstawowe (Szacowany)

8 października 2027

Ukończenie studiów (Szacowany)

5 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

13 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 października 2026

Pierwszy wysłany (Rzeczywisty)

19 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A5420
  • 39030 (Inny identyfikator: DAIDS Document ID)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Individual participant data that underlie results in the publication, after deidentification.

Ramy czasowe udostępniania IPD

Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally (ACTG) by NIH

Kryteria dostępu do udostępniania IPD

With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.

For what types of analyses? To achieve aims in the proposal approved by the ACTG.

By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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