Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Last updated: October 30, 2025
Sponsor: Midway Specialty Care Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hiv

Aids And Aids Related Infections

Hiv Infections

Treatment

Cabotegravir Injection [Apretude]

Clinical Study ID

NCT06145854
2022-01
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Cabotegravir Injection [Apretude]
Phase:
Study Start date:
January 02, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Midway Specialty Care Center

    Orlando, Florida 32819
    United States

    Site Not Available

  • Midway Specialty Care Center

    Temple Terrace, Florida 33617
    United States

    Site Not Available

  • Midway Specialty Care Center

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Midway Specialty Care Center

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Midway Specialty Care Center

    Temple Terrace 4174969, Florida 4155751 33617
    United States

    Site Not Available

  • Midway Specialty Care Center

    West Palm Beach 4177887, Florida 4155751 33401
    United States

    Site Not Available

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