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Integrase Inhibitor

Cabotegravir 400 mg/mL 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up injection 2 week 12 to week 52 follow-up
Awards & highlights

Study Summary

This trial is testing the safety and how well a long-acting cabotegravir injection works in healthy adults when given as an intramuscular or subcutaneous injection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~injection 2 week 12 to week 52 follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and injection 2 week 12 to week 52 follow-up 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-t) for cabotegravir (Part 1 Injection 2)
AUC(0-t) for cabotegravir (Part 2 Injection 1)
AUC(0-t) for cabotegravir (Part 2 Injection 2)
+26 more
Secondary outcome measures
AUC(0-t) for cabotegravir following oral 30 mg administration
AUC(0-t) of cabotegravir for cohort 4h
Cmax for cabotegravir following oral 30 mg administration
+10 more

Trial Design

15Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Cohort 6: CAB 400 mg/mL IM (gluteus medius)Experimental Treatment2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. Participants will then receive two IM gluteal injections of CAB 400 mg/mL formulation administered 12 weeks apart. The determination of the dose and dosing schedule will be governed by the STR.
Group II: Part 2: Cohort 5: CAB 400 mg/mL IM (gluteus medius)Experimental Treatment2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 800 mg as 1 x 2 mL CAB 400 mg/mL via IM (gluteus medius) injection. Participants will receive a second injection of CAB 400 mg/mL formulation via IM (gluteal injection) 12 weeks apart. The determination of the dose of the second injection will be governed by the Study Team safety and PK Review (STR).
Group III: Part 1:Cohort 3: CAB 400 mg/mL IM (lateral thigh)Experimental Treatment2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 1.5 mL or 400 mg given as 1 x 1 mL CAB 400 mg/mL formulation via IM (lateral thigh) injection. Participants will receive a second injection of CAB 400 mg given as 1 x 1 mL CAB 400 mg/mL via IM (lateral thigh) at Week 4.
Group IV: Part 1:Cohort 2: CAB 400 mg/mL SC abdominalExperimental Treatment2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 1.5 mL CAB 400 mg/mL formulation via SC abdominal injection. Participants will receive a second injection of CAB 200 mg given as 1 x 0.5 mL CAB 400 mg/mL via SC abdominal at Week 4.
Group V: Part 1:Cohort 1: CAB 400 mg/mL IM glutealExperimental Treatment2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 1.5 mL CAB 400 mg/mL formulation via IM gluteal injection. Participants will receive a second injection of CAB 400 mg given as 1 x 1 mL CAB 400 mg/mL via IM gluteal injection at Week 4.
Group VI: Part 1: Cohort 4h: CAB 400 mg/mL (SC)Experimental Treatment3 Interventions
Group VII: Part 1: Cohort 4b: CAB 400 mg/mL (SC)Experimental Treatment5 Interventions
Group VIII: Part 1: Cohort 4: CAB 400 mg/mL (IM or SC)Experimental Treatment2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 400 mg as 1 x 1 mL CAB 400 mg/mL via IM (gluteal injection). Participants will receive a second injection of 200 mg as 1 x 0.5 mL CAB 400 mg/mL via SC (abdominal) at Week 4.
Group IX: Part 1:Cohort 1: CAB 200 mg/mL IM glutealActive Control2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 600 mg given as 1 x 3 mL CAB 200 mg/mL via IM gluteal injection. Participants will receive a second injection of CAB 400 mg given as 1 x 2 mL CAB 200 mg/mL via IM gluteal injection at Week 4.
Group X: Part 2: Cohort 6: CAB 200 mg/mL IM (gluteus medius)Active Control2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. Participants will then receive two IM gluteal injections of CAB 200 mg/mL formulation administered 12 weeks apart. The determination of the dose and dosing schedule will be governed by the STR.
Group XI: Part 1: Cohort 4h: CAB 200 mg/mL (SC)Active Control3 Interventions
Group XII: Part 1:Cohort 2: CAB 200 mg/mL SC abdominalActive Control2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of CAB 300 mg as 1x 1.5 mL CAB 200 mg/mL via SC abdominal injection. Participants will receive a second injection of CAB 100 mg as 1 x 0.5 mL CAB 200 mg/mL SC abdominal at Week 4.
Group XIII: Part 1:Cohort 3: CAB 200 mg/mL IM (lateral thigh)Active Control2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 600 mg given as 1 x 3 mL or 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (lateral thigh) injection. Participants will receive a second injection of 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (lateral thigh) at Week 4.
Group XIV: Part 1: Cohort 4: CAB 200 mg/mL (IM or SC)Active Control2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (gluteal injection). Participants will receive a second injection of 100 mg as 1 x 0.5 mL CAB 200 mg/mL via SC (abdominal) at Week 4.
Group XV: Part 2: Cohort 5: CAB 200 mg/mL IM (gluteus medius)Active Control2 Interventions
Eligible participants will receive 1 tablet of CAB 30 mg once daily for 28 days during the oral lead-in phase, followed by a wash out period of 7 to 14 days. On Day 1 of Part 1, participants will be administered a loading dose of 400 mg as 1 x 2 mL CAB 200 mg/mL via IM (gluteus medius) injection. Participants will receive a second injection of CAB 200 mg/mL formulation via IM (gluteal injection) 12 weeks apart. The determination of the dose of the second injection will be governed by the STR.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical steroid
2020
Completed Phase 1
~140
Hyaluronidase (human recombinant)
FDA approved
Topical non-steroidal anti-inflammatory drug
2020
Completed Phase 1
~140
Placebo creams/gels
2020
Completed Phase 1
~140
Cabotegravir sodium (Oral Lead In)
2020
Completed Phase 1
~140
Cabotegravir 400 mg/mL
2020
Completed Phase 1
~140

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
468,405 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,792 Total Patients Enrolled

Frequently Asked Questions

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

Can you please provide a synopsis of prior research involving Cabotegravir 400 mg/mL?

"GlaxoSmithKline Investigational Site initiated the exploration of cabotegravir 400 mg/mL in 2014, with a total of 27 finished trials to date. Currently 15 studies are underway and many can be found operating from Orlando, Florida."

Answered by AI

Is this research initiative currently open for enrollment?

"At this moment in time, no additional patients are being admitted to the trial. Initially posted on July 31st 2020 and most recently edited on September 7th 2022, any individuals hoping to join should look towards other studies as there are currently 484 clinical trials for HIV-infected participants and 15 actively recruiting Cabotegravir 400 mg/mL experiments."

Answered by AI

Has the Food and Drug Administration approved Cabotegravir 400 mg/mL?

"Due to the preliminary nature of this clinical trial, our team at Power has assessed cabotegravir 400 mg/mL's safety as a 1 on a three-point scale. This is because there are limited data points in both efficacy and safety investigations."

Answered by AI

Are geriatric individuals being considered for inclusion in the trial?

"This medical study has an age restriction of 18-50 years old, and is inviting individuals within this range to participate."

Answered by AI

What are the common medical applications for Cabotegravir 400 mg/mL?

"Cabotegravir 400 mg/mL is indicated for HIV-negative patients, those who weigh at least 35 kg, treatment failure cases and individuals with virological suppression."

Answered by AI

What is the aggregate number of individuals enrolled in this research?

"Sadly, this trial is no longer seeking participants. The listing was initially uploaded on July 31st 2020 and last modified on September 7th 2022. If you're looking for other trials that may be suitable, there are 484 studies recruiting HIV patients while 15 are offering Cabotegravir 400 mg/mL treatments."

Answered by AI

What type of participants is the medical trial recruiting?

"This medical trial has set a criteria for participants to have HIV and be between 18-50 years old. 138 individuals are being actively recruited by the clinical team."

Answered by AI

Does this clinical trial have a substantial presence in the United States?

"At present, this trial is enrolling patients from 4 separate locations; these are based in Orlando, Las Vegas and Berlin along with an additional medical centre. To reduce the burden of travel during your involvement in the research program it is recommended that you attend a clinic nearest to yourself."

Answered by AI

Has this investigation been performed before, or is it a pioneering effort?

"Since 2014, Janssen Pharmaceuticals has been researching Cabotegravir 400 mg/mL; their initial trial was conducted in the same year and comprised of 309 participants. Afterward, Phase 2 drug approval was granted to this medication with 15 current studies being held across 155 cities & 30 nations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
2020. "Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04484337.
~30 spots leftby Apr 2025
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