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A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals. Version 1.0 07/05/2018

Study category: Infectious Diseases

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Details
Age

Adult

Eligibility

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.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Thomas Campbell,  MD

Thomas Campbell, MD

Study ID

Protocol Number: 18-1493

ClinicalTrials.gov: NCT03635788

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