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NCT06145854 | RECRUITING | Hiv

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP
Sponsor:

Midway Specialty Care Center

Information provided by (Responsible Party):

Emmanuelle

Brief Summary:

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.

Condition or disease

Hiv

Intervention/treatment

Cabotegravir Injection [Apretude]

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Real World Clinical Outcomes in Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP: An Observational, Multisite Prospective 2 Year Study in the Southern U.S.
Actual Study Start Date : 2024-01-02
Estimated Primary Completion Date : 2026-10-30
Estimated Study Completion Date : 2027-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Criteria
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
Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Location Details

NCT06145854

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Midway Specialty Care Center

Orlando, Florida, United States, 32819

NOT YET RECRUITING

United States, Florida

Midway Specialty Care Center

Temple Terrace, Florida, United States, 33617

RECRUITING

United States, Florida

Midway Specialty Care Center

West Palm Beach, Florida, United States, 33401