Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT02475655
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    10 mg orally twice daily for 5 weeks

Study Details

The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART).

Key Dates

Start date
May 16, 2016
Status verified
Jul 2020
Primary completion
Feb 18, 2018
Completion
Apr 4, 2018

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Ruxolitinib
    Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.
  • No Intervention: Arm B: No Study Treatment
    Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study.

Primary Outcome Measure

Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment [ Time Frame: Entry to Week 5 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35294-
UCLA CARE Center CRSLos AngelesCalifornia90035-
UCSD Antiviral Research Center CRSSan DiegoCalifornia92103-
Ucsf Hiv/Aids CrsSan FranciscoCalifornia94110-
Northwestern University CRSChicagoIllinois60611-
Washington University Therapeutics (WT) CRSSt LouisMissouri63110-1010-
Weill Cornell Chelsea CRSNew YorkNew York10010-
Weill Cornell Uptown CRSNew YorkNew York10065-
University of Rochester Adult HIV Therapeutic Strategies Network CRSRochesterNew York14642-
Cincinnati Clinical Research SiteCincinnatiOhio45219-
Case Clinical Research SiteClevelandOhio44106-
Penn Therapeutics, CRSPhiladelphiaPennsylvania19104-
The Miriam Hospital Clinical Research Site (TMH CRS) CRSProvidenceRhode Island02906-
Vanderbilt Therapeutics (VT) CRSNashvilleTennessee37204-

Find similar trials in Birmingham, AL

By condition
HIV
By specialty
Infectious disease
By research site
Alabama CRS· Birmingham, ALUCLA CARE Center CRS· Los Angeles, CAUCSD Antiviral Research Center CRS· San Diego, CAUcsf Hiv/Aids Crs· San Francisco, CANorthwestern University CRS· Chicago, ILWashington University Therapeutics (WT) CRS· St Louis, MO

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