a study on HIV/AIDS
The purpose of this study is to evaluate the safety and tolerability of ruxolitinib in HIV-infected adults who are virologically suppressed and who are on antiretroviral therapy (ART).
A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults
Ruxolitinib is a medication approved by the U.S. Food and Drug Administration (FDA) to treat myelofibrosis, a disorder in which bone marrow is replaced by scar (fibrosis) tissue. Many of the cytokines affected by myelofibrosis are also affected by HIV. Because of this, ruxolitinib may also be a possible treatment for HIV. The purpose of this study is to evaluate the safety and tolerability of ruxolitinib in HIV-infected adults who are on ART and who are virologically suppressed. Researchers will evaluate the effect ruxolitinib has on inflammation and immune activation.
This study will enroll HIV-infected adults who are on select ART regimens and who have viral suppression. ART will not be provided by the study; participants will continue to receive ART from their own health care providers. Participants will be randomly assigned to receive either ruxolitinib (Arm A) or no study treatment (Arm B). Participants in Arm A will receive ruxolitinib twice a day for 5 weeks. All participants will attend study visits at entry (Day 0) and Weeks 1, 2, 4, 5, 10, and 12. These visits will include physical examinations, clinical assessments, blood collection, adherence assessments, oral swab collection, and pregnancy testing for female participants. At Weeks 1 and 4, participants in Arm A will take part in pharmacokinetic (PK) sampling, which will involve having blood drawn several times over 6 to 8 hours.
Open to people ages 18 years to 75 years
Gault equation). NOTE: A calculator for estimating the CrCl can be found at www.fstrf.org/ACTG/ccc.html
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02475655.
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