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Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

NCT04824131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-12-03

Study results available
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Summary

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

Conditions

  • HIV Infections

Interventions

DRUG

Oral cabotegravir (CAB)

30 mg tablets

DRUG

CAB LA

Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter

DRUG

Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)

300 mg/200 mg fixed-dose combination tablets

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sybil Hosek, PhD · Stroger Hospital of Cook County

  • Lynda Stranix-Chibanda, MBChB, MMED · University of Zimbabwe College of Health Sciences

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2023-01-10
Completion
2023-01-10
FDA Drug
Yes

Countries

  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824131 on ClinicalTrials.gov