Phase
Condition
N/ATreatment
Cabotegravir LA + Rilpivirine LA
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be able to understand and comply with protocol requirements, instructions, andrestrictions.
Understand the long-term commitment to the study and be likely to complete the studyas planned.
Be considered appropriate candidates for participation in an investigative clinicaltrial with oral and intramuscularly injectable medications (e.g., no activesubstance use disorder, acute major organ disease, or planned long-term workassignments out of the country, etc.).
Must be on a stable antiretroviral regimen without present or past evidence of viralresistance to, and no prior virological failure with agents of the NNRTI and INIclass.
Plasma HIV-1 RNA <50 copies/mL at screening.
A female subject is eligible to participate if she is not pregnant (as confirmed bya negative serum hCG test at screen and a negative urine hCG test at randomization)and not lactating
Exclusion
Exclusion Criteria:
Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blipsare allowed (increased viral load ≥50 copies/mL but <200 copies/mL preceded andfollowed by a viral load less than 50 copies/mL)
Any drug holiday during the window between initiating first HIV ART and 6 monthsprior to screening, except for brief periods (less than 1 month) where all ART wasstopped due to tolerability and/or safety concerns.
Any switch to a second line regimen, defined as change of a single drug or multipledrugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as aconfirmed plasma HIV-1 RNA measurement ≥200 copies/mL after initial suppression to <50 copies/mL while on first line HIV therapy regimen)
Subjects who are currently participating in or anticipate being selected for anyother interventional study. Observational studies and intervention studies that donot include treatments are allowed unless they interfere with scheduled visits.
Participants receiving any prohibited medication and who are unwilling or unable toswitch to an alternative medication
Study Design
Connect with a study center
Hospital General Universitario de Elche
Elche, Alicante 03203
SpainSite Not Available
Hospital Marina Baixa
Villajoyosa, Alicante 03570
SpainSite Not Available
Hospital General Universitario Santa Lucía
Cartagena, Murcia 30202
SpainSite Not Available
Hospital Universitario Rafael Mendéz de Lorca
Lorca, Murcia 30813
SpainSite Not Available
Hospital General Universitario Los Arcos del Mar Menor
Pozo Aledo, Murcia 30739
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Arrixaca Murcia
Murcia, 30100
SpainSite Not Available
Hospital General Universitario Morales Meseguer
Murcia, 30008
SpainSite Not Available
Hospital General Universitario Reina Sofia
Murcia, 30003
SpainActive - Recruiting
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