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Integrase Inhibitor

CAB LA for Human Immunodeficiency Virus Infection

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through participant's last study visit, up to 1.5 years after study entry.
Awards & highlights

Study Summary

This trial will help researchers understand how safe and effective a cabotegravir long-acting injection is for adolescents. If the results are positive, it could change the way we prevent HIV in young people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through participant's last study visit, up to 1.5 years after study entry.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through participant's last study visit, up to 1.5 years after study entry. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability endpoint: Proportion of participants who complete all scheduled injections and proportion of participants who receive at least one injection whom would consider using CAB LA for HIV prevention in the future.
Safety endpoint: Proportion of participants experiencing any Grade 2 or higher clinical adverse events (AEs) and laboratory abnormalities among participants who receive at least one injection of CAB LA.
Tolerability endpoint: Proportion of participants who receive at least 1 injection and who discontinue receiving injections prior to the full course of injections due to intolerability of injection, frequency of injections or burden of study procedures.
Secondary outcome measures
Characterize CAB drug concentrations in individuals who acquire HIV.
Pharmaceutical Preparations
Plasma CAB Drug Measurements
+2 more

Side effects data

From 2023 Phase 3 trial • 437 Patients • NCT04399551
80%
Injection site pain
18%
COVID-19
11%
Injection site induration
10%
Pyrexia
10%
Headache
9%
Injection site discomfort
8%
Back pain
7%
Diarrhoea
7%
Nasopharyngitis
7%
Injection site nodule
6%
Injection site swelling
6%
Asthenia
5%
Arthralgia
5%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patient Study Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAB LAExperimental Treatment3 Interventions
In Step 1, participants will receive one CAB tablet orally every day for 5 weeks. In Step 2, participants will receive an intramuscular (IM) injection of CAB LA at Weeks 5, 9, 17, 25, and 33. In Step 3, participants will receive a TDF/FTC tablet orally every day for 48 weeks or may be offered the opportunity to join an open label CAB study instead, if such a study is being implemented in their area at the time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabotegravir (CAB) tablet
2020
Completed Phase 2
~10
CAB LA
2018
Completed Phase 3
~650
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
2020
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,277 Previous Clinical Trials
5,487,444 Total Patients Enrolled
Sybil Hosek, PhDStudy ChairStroger Hospital of Cook County
10 Previous Clinical Trials
810 Total Patients Enrolled
Lynda Stranix-Chibanda, MBChB, MMEDStudy ChairUniversity of Zimbabwe College of Health Sciences
3 Previous Clinical Trials
2,205 Total Patients Enrolled
~2 spots leftby Jun 2025
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