Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Midway Specialty Care Center

Status: Enrolling

Conditions: Hiv

Treatments: Drug: Cabotegravir Injection [Apretude]

Study type: Observational

Funder types: Other

Identifiers

NCT06145854

2022-01

Details and patient eligibility

About

Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cisgender females, ages 18 years and older
2. Negative HIV test at baseline
3. Negative Pregnancy test at baseline
4. Weigh at least 35 kilograms
5. Already Prescribed CAB-LA (Apretude)

Exclusion criteria

1. Transgender females or males
2. Cisgender males
3. Cisgender female who is actively breastfeeding
4. Severe hepatotoxicity
5. Evidence of Hepatitis B Infection
6. History or presence of allergies to cabotegravir or its components

Trial design

100 participants in 1 patient group

Cisgender Females

Treatment:

Drug: Cabotegravir Injection [Apretude]