Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

NCT ID: NCT06145854

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-02

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hiv

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cisgender Females

Cabotegravir Injection [Apretude]

Intervention Type DRUG

Apretude for PrEP

Interventions

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Cabotegravir Injection [Apretude]

Apretude for PrEP

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Midway Specialty Care Center

OTHER

Sponsor Role lead

Responsible Party

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Emmanuelle Allseits

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Midway Specialty Care Center

Orlando, Florida, United States

Site Status

Midway Specialty Care Center

Temple Terrace, Florida, United States

Site Status

Midway Specialty Care Center

West Palm Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2022-01

Identifier Type: -

Identifier Source: org_study_id

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