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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
3,268 Previous Clinical Trials
5,481,123 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the typical purpose of an administration of CAB LA?

"CAB LA is primarily utilized to ameliorate the effects of HIV-1, yet it can also be applied in the treatments of other similar conditions such as HIV infections and transmission."

Answered by AI

Is recruitment for this research project still open?

"According to the clinicaltrials.gov database, this particular study is not currently seeking for patients. It was first listed on February 19th 2020 and last updated November 8th 2022, however there are 590 other trials actively looking for volunteers at present."

Answered by AI

What is the ultimate purpose of this clinical experiment?

"This clinical trial will evaluate the safety of CAB LA over 1.5 years, identified by a proportion of participants experiencing Grade 2 or higher adverse events and laboratory abnormalities; additionally, the study aims to measure the amount of visits which remain above particular concentrations in order to determine rectal protection. Furthermore, this research seeks to gain insight into drug concentration levels among those who acquire HIV through their involvement with the trial."

Answered by AI

Has the Food and Drug Administration given a stamp of approval to CAB LA?

"Although there is little evidence of CAB LA's efficacy, data does exist to support its safety and therefore earned a score of 2."

Answered by AI

How many participants have been enrolled in this clinical trial?

"This clinical trial is no longer actively accepting patients, as the study was initially posted in February of 2020 and last updated on November 8th 2022. If you are interested in similar studies, there are presently 485 trials for HIV infections and 105 trials for CAB LA that require participants."

Answered by AI

To what extent is this exploration being conducted in various sites?

"This research is being conducted out of St. Jude Children's Research Hospital ATN CRS in Memphis, TN, University of Colorado Denver ATN CRS in Aurora, CO and John H. Stroger Jr. Hosp. Of Cook County ATN CRS in Chicago il along with some other sites."

Answered by AI

Could you provide information regarding the precedential research involving CAB LA?

"Presently, 105 clinical trials have been launched to research CAB LA. 35 of those ongoing studies are in the third phase, and 2057 medical locations across the world are hosting these experiments. Notably, many of these projects originate from Boylston, Massachusetts."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
2020. "Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04692077.
~2 spots leftby Apr 2025
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