A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018
Inclusion: -PLWH who are 18 years of age or older. -Prescribed ART for at least 6 months. -Screening HIV RNA is greater than 200 copies. -Women must not be pregnant, planning to become pregnant, or breastfeeding. Women who can become pregnant must agree to use 1 form of effective birth control. -There is evidence of non-adherence to their HIV medications. Non-adherence to HIV medications will be defined as having one of the two criteria below: 1. Poor virologic response within the last 18 months (defined as <1 log10 decrease in HIV-1 RNA from the participant's historical baseline value or HIV-1 RNA >200 copies/mL at two time points at least 4 weeks apart) in individuals who have been prescribed ART for at least 6 consecutive months. 2. Lost to clinical follow-up within the last 18 months with ART non-adherence for more than 6 consecutive months. Lost to clinical follow-up is defined as either no contact with provider or missed 2 or more appointments in a 6-month period. ART non-adherence is defined as a lapse in ART more than 7 days (consecutive or non-consecutive), in the 6-month period where they were lost to clinical follow-up per participant report. Exclusion: -Previous use of rilpivirine or cabotegravir. -Uncontrolled seizures. -Advanced liver disease. -Unwilling to receive injections in the buttocks. -Chronic Hepatitis C with planned or anticipated use of anti-HCV therapy prior to the completion of step 2. -Active Hepatitis B infection.
University of Colorado Hospital
Thomas Campbell, MD
Protocol Number: 18-1493
More information available at ClinicalTrials.gov: NCT03635788
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