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

10. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35222
        • Alabama CRS (Site #31788)
        • Ta kontakt med:
    • California
      • Los Angeles, California, Forente stater, 90035
        • University of California, Los Angeles CARE Center CRS (Site #601)
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92103
        • UCSD Antiviral Research Center CRS (Site #701)
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94110
        • University of California, San Francisco HIV/AIDS CRS (Site #801)
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20009
        • Whitman-Walker Institute, Inc. CRS (Site #31791)
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308-2012
        • The Ponce de Leon Center CRS (Site #5802)
        • Ta kontakt med:
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital CRS (MGH CRS) (Site #101)
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10032
        • Columbia Physicians & Surgeons (P&S) CRS (Site #30329)
        • Ta kontakt med:
      • Rochester, New York, Forente stater, 14642
        • University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site #31787)
        • Ta kontakt med:
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7215
        • Chapel Hill CRS (Site #3201)
        • Ta kontakt med:
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267-0405
        • Cincinnati Clinical Research Site (Site #2401)
        • Ta kontakt med:
      • Cleveland, Ohio, Forente stater, 44106
        • Case Clinical Research Site (Site #2501)
        • Ta kontakt med:
          • George Yendewa
          • Telefonnummer: 216-844-2298
          • E-post: gay7@case.edu
      • Columbus, Ohio, Forente stater, 43210-1282
        • Ohio State University CRS (Site #2301)
        • Ta kontakt med:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh CRS (Site #1001)
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37204
        • Vanderbilt Therapeutics (VT) CRS (Site #3652)
        • Ta kontakt med:
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Houston Advancing Research Team CRS (Site #31473)
        • Ta kontakt med:
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • University of Washington Positive Research CRS (Site #1401)
        • Ta kontakt med:
          • Rachel Bender Ignacio
          • Telefonnummer: 206-744-4876
          • E-post: rbi13@uw.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Ixazomib

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

Andre navn:
  • Ninlaro
  • MLN9708
Placebo komparator: Placebo

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of Ixazomib-Treated Participants With at Least One Grade 3 or Higher Adverse Event Related to Study Treatment.
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24
Weeks 1, 2, 3, 4, 6, 10, 12, 16, 20, and 24

Sekundære resultatmål

Resultatmål
Tidsramme
Intact Proviral DNA Levels Measured by the Intact Proviral DNA Assay (IPDA)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Screening, Entry (Week 0), and Weeks 4, 24, and 28
Screening, Entry (Week 0), and Weeks 4, 24, and 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

Takeda

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

23. november 2026

Primær fullføring (Antatt)

8. oktober 2027

Studiet fullført (Antatt)

5. november 2027

Datoer for studieregistrering

Først innsendt

13. oktober 2026

Først innsendt som oppfylte QC-kriteriene

13. oktober 2026

Først lagt ut (Faktiske)

19. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A5420
  • 39030 (Annen identifikator: DAIDS Document ID)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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