A5336: A Study of Ruxolitinib in ART-Treated HIV-1 Infected Adults


Protocol Summary and Purpose of this Study:  ruxolitinib

This is a randomized, open-label, two-arm (phase IIa) study of ruxolitinib in HIV-infected adults. Eligible participants on select antiretroviral therapy (ART) with virologic suppression will be randomized to receive ruxolitinib or no study treatment to measure safety, tolerability, PK and to determine whether there are changes in systemic immune activation and inflammation after 5 weeks of treatment with ruxolitinib.

https://clinicaltrials.gov/ct2/show/NCT02475655

Objectives:

  • To evaluate the safety and tolerability of ruxolitinib in ART-treated HIV-1 infected virologically suppressed participants during 5 weeks of treatment.
  • To compare changes in levels of interleukin-6 (IL-6) and other markers of inflammation and immune activation between baseline and week 5 in ART-treated HIV-1 virologically suppressed participants who are randomized to ruxolitinib and those randomized to receive no study treatment.

Requirements to Enter Study:

  • HIV-1 positive men and women, > 18 and <75 years old;

  • CD4+ T cell count > 350 cells/mm3

  • Continuous ART for > 2 years with documented virologic suppression > 2 years (one blip 500 or below allowed in the 48 weeks before study entry);

  • Current regimen must contain dual nucleoside/tide combination of either TDF/FTC, TAF/FTC, TDF+3TC, ABC/3TC + a NNRTI or INSTI, not containing cobicistat, for at least 60 days, inclusive, prior to study entry;

  • ANC > 1000/mm3, Hgb > 12.0 g/dL, Plts > 200,000/mm3, LFTs < 1.5xULN

  • CrCl > 80mL/min or > 70 mL/min for participants on a DTG-containing regimen;

  • No changes in ART in 12 weeks prior to study entry;

  • No history of progressive multifocal leukoencephalogpathy;

  • No history of untreated latent tuberculosis infection diagnosed by tuberculin skin test or interferon gamma release assay;

  • Not currently prescribed any CYP3A4 inhibitors or inducers;

  • No diagnosis of CDC Cat C AIDS-indicator conditions, herpes zoster (dermatomal or non-dermatomal) or lymphoproliferative malignancy in the 2 years prior to study entry. A history of chicken pox is not exclusionary.

Treatment:

Randomized at entry to either

  • ARM A: Ruxolitinib 10 mg orally (PO) BID. Participants must remain on ART regimen (not provided by the study) for the duration of the study.
  • ARM B: No study treatment. Participants will be encouraged to remain on ART regimen (not provided by the study) for the duration of the study.

Duration of Study:

The trial lasts for 12 weeks on study. Compensation provided. Bus tickets/parking provided. There are 7 visits (including screening and pre-entry visit).