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Antiretroviral Therapy

CABENUVA for HIV (GLACIER Trial)

Phase 4

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

Adults (greater than or equal to [>=]18 years old) at the time of signing the informed consent.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1, 4 and 8

Awards & highlights

GLACIER Trial Summary

This trial is examining the administration of CABENUVA, a long-acting medication for HIV, in infusion centers in the United States. The acceptability and feasibility of the infusion center to deliver CABENUVA injections will be assessed from the perspectives of the participants, HIV care providers and IC staff.

Who is the study for?

This trial is for adults over 18 with HIV-1 who are prescribed CABENUVA. They must have taken oral HIV treatments or CABENUVA injections as per guidelines before joining. The study excludes those with conditions or on medications not allowed by the CABENUVA Prescribing Information, and anyone who's had more than three injections at an infusion center before the study.Check my eligibility

What is being tested?

The GLACIER study tests how well infusion centers or alternate sites can administer CABENUVA intramuscular injections to treat HIV-1. It focuses on whether these locations are acceptable and feasible from the viewpoints of patients, healthcare providers, and site staff.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants may experience reactions related to CABENUVA which includes Cabotegravir LA and Rilpivirine LA. Side effects could be similar to those noted in general use such as injection site reactions, liver problems, depression or mood changes.

GLACIER Trial Eligibility Criteria

Inclusion Criteria

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

GLACIER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1, 4 and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1, 4 and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1, 4 and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the Feasibility of Intervention Measure (FIM)

Secondary outcome measures

Acceptability of CABENUVA administration at infusion center/ ASA assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8

Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in HIV care providers at Month 1, 4 and 8

Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in IC/ ASA Staff prior to Month 1 and Months 3 and 8

+49 more

GLACIER Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants receiving CABENUVAExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,499 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,886 Total Patients Enrolled

Media Library

CABENUVA (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04982445 — Phase 4

Human Immunodeficiency Virus Infection Research Study Groups: Participants receiving CABENUVA

Human Immunodeficiency Virus Infection Clinical Trial 2023: CABENUVA Highlights & Side Effects. Trial Name: NCT04982445 — Phase 4

CABENUVA (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04982445 — Phase 4

Frequently Asked Questions

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

What potential hazards come with taking CABENUVA?

"Given its approval as a Phase 4 treatment, CABENUVA was rated 3 for safety by our Power team."

Answered by AI

How many medical centers are running this clinical experiment?

"Currently, 21 different medical sites are opening their doors to participate in this clinical trial. Options include centres located in Charlotte, Charleston and Columbia as well as 18 other locations across the country. To reduce travel demands associated with participation, we suggest selecting the clinic closest to you."

Answered by AI

Has CABENUVA been explored in any other scientific investigations?

"Currently, CABENUVA has 20 active clinical trials with 7 having reached Phase 3. Primarily centered in Pathum Wan, Bangkok, there are 639 sites conducting studies on this drug's efficacy."

Answered by AI

What conditions is CABENUVA typically employed to treat?

"CABENUVA is commonly prescribed to individuals who are HIV test negative. Additionally, this drug may be beneficial in treating cases of treatment failure, viral resistance, and when the HIV-1 RNA count is less than or equal to 100,000 copies/ml."

Answered by AI

Are there any vacancies left for participants in this investigation?

"As per clinicaltrials.gov, this research project is presently enlisting participants. It was initially announced on November 18th 2021 and the latest update came out on November 21st 2022."

Answered by AI

How many participants in this research project are currently being monitored?

"Correct. According to the information on clinicaltrials.gov, this study was originally posted in November 2021 and is presently recruiting participants for a total of 120 patients from 21 different sites. The listing was last modified on 11/21/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)

2021. "Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04982445.

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