Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa

• Status: Withdrawn
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA) injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in KwaZulu-Natal, South Africa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for the AIDS Programme of Research in South Africa
• Collaborator: ViiV Healthcare
• Treatments: Cabotegravir; HIV Integrase Inhibitors; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Able and willing to provide written informed consent to be screened for, and to enrol in, the study.

• Able and willing to provide adequate locator information for study retention purposes.

• Sexually active, defined as having had vaginal intercourse at least once in the past 30 days prior to screening.

• HIV negative on testing performed by study staff

• Have a negative pregnancy test performed by study staff

• Agree to use a non-barrier form of contraceptive

• Agree to adhere to study visits and procedures.

• Haemoglobin > 11 g/dL,

• ALT < ULN

• AST < ULN

• Total bilirubin < Grade 1

• Direct bilirubin < ULN

• Creatinine clearance ≥60 mL/min

• Hepatitis B surface antigen (HBsAg) negative

• Hepatitis C Ab negative

• In general good health, as assessed clinically

Exclusion Criteria:

• Past or current participation in any other HIV interventional research study or other concurrent studies which may interfere with this study.

• Clinically significant cardiovascular disease, including:

• ECG with:

• heart rate <50 or >100 beats per minute (one repeat ECG is allowed during screening; can be performed on the same day)

• QRS duration >120 msec

• QTc interval (B or F) > 450 msec

• evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)

• any conduction abnormality (including but not specific to left or right complete bundle branch block, Atrioventricular block [2nd degree (type II) or higher], Wolf Parkinson White syndrome)

• sinus pauses > 3 seconds

• any significant arrhythmia which, in the opinion of the Principal Investigator or designee, will interfere with the safety for the individual participant

• history of non-sustained (3 consecutive ventricular ectopic beats on ECG at screening or entry) or sustained ventricular tachycardia

• History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease

• Underlying skin disease or currently active skin disorder (e.g., infection, inflammation, dermatitis, eczema, psoriasis, urticaria). Mild cases of localized disease or other mild skin condition may not be exclusionary at the discretion of the Principal Investigator or designee.

• Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the Principal Investigator or designee, may interfere with interpretation of injection site reactions.

• History of acute or chronic liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy).

• Coagulopathy (primary or iatrogenic) which would contraindicate IM injection.

• Active or planned use of prohibited medications as described in the SSP manual (updated regularly from the Investigator's Brochure).

• Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study.

• Known Hypersensitivity to egg, soya or peanut protein.

• Has any other condition that, based on the opinion of the Principal Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.