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Integrase Inhibitor

CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2) for Human Immunodeficiency Virus Infection

Phase 1
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF).
Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 168 hours
Awards & highlights

Study Summary

This trial tests how well a medicine works, and if it works differently when taken with food.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 168 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC(0-inf) following administration of CAB DT in fasted state
AUC(0-inf) following administration of CAB IR in fasted state
AUC(0-last) following administration of CAB DT in fasted state
+6 more
Secondary outcome measures
AUC(0-72) following administration of CAB DT in fasted state
AUC(0-72) following administration of CAB IR in fasted state
Absolute values of chemistry parameters: ALT, ALP, AST and Creatine phosphokinase (International units per liter)
+49 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1)Experimental Treatment3 Interventions
Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Group II: CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2)Experimental Treatment3 Interventions
Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment .
Group III: CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1)Experimental Treatment3 Interventions
Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Group IV: CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference)Experimental Treatment3 Interventions
Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Group V: CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference)Experimental Treatment3 Interventions
Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Group VI: CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2)Experimental Treatment3 Interventions
Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabotegravir DT Formulation (test 2)
2023
Completed Phase 1
~30
Cabotegravir DT Formulation (test 1)
2023
Completed Phase 1
~30
Cabotegravir IR Formulation (reference)
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,624 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,593 Previous Clinical Trials
6,143,329 Total Patients Enrolled

Frequently Asked Questions

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

Does the protocol for this investigation encompass participants over fifty-five years of age?

"This medical trial is recruiting participants that are 18 years and older, but younger than 55."

Answered by AI

Can I be part of this medical experiment?

"Eligibility for this trial necessitates HIV infection and an age range between 18 to 55. This research is presently recruiting 24 participants."

Answered by AI

Are participants being recruited for this experiment currently?

"Reportedly, patient recruitment for this medical trial is ongoing. It was first advertised on March 23rd 2023 and the most recent update occurred April 20th of that same year."

Answered by AI

What potential health risks could be associated with CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1)?

"CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1) have been assigned a safety score of 1 as this is its first clinical trial; therefore, there are limited data available in regard to its efficacy and security."

Answered by AI

How many individuals are eligible for participation in this experiment?

"Affirmative. As per the clinicaltrials.gov website, this medical trial began recruitment on March 23rd 2023 and is currently open for applications. The study requires 24 volunteers from a single location to fill its ranks."

Answered by AI
~12 spots leftby Mar 2025