Phase
Condition
Hiv Infections
Treatment
CAB ULA
CAB LA
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult participants greater than or equal to (>=) 18 years old, weighing at least 35kg.
Participants who are overtly healthy as determined by medical evaluation.
Assigned male sex at birth or assigned female sex at birth. Participants assignedfemale sex at birth are eligible to participate if they are of non-childbearingpotential, or if they are of childbearing potential and are not pregnant (confirmedby test), not breastfeeding, and are using a highly effective contraceptive method.
Capable of giving written informed consent.
Healthcare staff will be eligible for inclusion in this study if:
They are site employees responsible for administrative or clinical aspects ofoffering and administering CAB under the protocol at the site.
Has the required qualifications according to their role and delegated theappropriate responsibilities by site Principal investigator (PI).
Be able to understand and comply with protocol requirements, instructions, andrestrictions.
Exclusion
Exclusion Criteria:
Presence or history of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, haematological, neurological, or psychiatric disorderscapable of significantly altering drug pharmacokinetics, interfering with theparticipant's ability to comply with the dosing schedule and/or protocolevaluations, or compromising participant safety.
Current or anticipated need for chronic anti-coagulants.
Any malignancy within the past 5 years except for basal cell or squamous epithelialcarcinomas of the skin that have been resected with no evidence of metastaticdisease for 3 years.
History of ongoing or clinically relevant seizure disorder within the previous 2years.
Participants who pose a significant suicidality risk.
History or presence of sensitivity to any of the study medications, studyprocedure-related medications, their components or drugs of their class, or anallergy that contraindicates participation.
Participant has an implant/enhancement (including fillers) at the area of proposedinjection; or tattoo or other dermatological condition overlying any area which maysignificantly interfere with interpretation of injection site reactions.
Inflammatory skin conditions that compromise the safety of injections.
Any acute laboratory abnormality that should preclude participation or exclusionarylaboratory value.
Human immunodeficiency virus (HIV-1 or HIV-2) infection.
Reactive or positive HIV test.
Signs and symptoms suggestive of acute HIV infection- that is not ruled out withnon-reactive results using appropriate HIV tests.
Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 monthsprior to first dose of study intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior tofirst dose of study intervention.
Positive hepatitis C RNA test result at screening or within 3 months prior to firstdose of study intervention.
One or more exclusionary values for a screening ECG.
Participants receiving any protocol-prohibited medication.
Use of CAB LA for PrEP within 1 year.
Concurrent participation in another clinical study in which an investigationalproduct was received within 30 days, 5 half-lives or twice the duration of thebiological effect of the investigational product (whichever is longer).
Participation in the study would result in loss of blood or blood products in excessof 500 mL within 56 days.
Exposure to more than 4 new chemical entities within 12 months prior to the firstdosing day.
Positive pre-study drug/alcohol screen.
History of or on-going high-risk behaviours that put the participant at increasedrisk for HIV infection.
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Mobile, Alabama 36608
United StatesActive - Recruiting
GSK Investigational Site
Coral Gables, Florida 33134
United StatesActive - Recruiting
GSK Investigational Site
Oak Brook, Illinois 60532
United StatesActive - Recruiting
GSK Investigational Site
Oakbrook, Illinois 60532
United StatesSite Not Available
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