Integrase Inhibitor

Participants Receiving VH3810109 Plus Cabotegravir for Human Immunodeficiency Virus Infection

GSK Investigational Site, Greensboro, NC
Cabotegravir +3 morePhase 2RecruitingResearch Sponsored by ViiV Healthcare

Study Summary

This trial evaluates if a new HIV drug combo is effective in adults already on therapy.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are not currently taking cabotegravir or fostemsavir medications.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Plasma HIV-1 Ribonucleic acid (RNA) Greater Than or Equal to (≥)50 Copies per Millilitre (c/mL) per Snapshot Algorithm at Month 6
Secondary outcome measures
Absolute Value for Cluster of Differentiation 4 (CD4+) T-Cell Count
Absolute Value for Cluster of Differentiation 8 (CD8+) T-Cell Count
Change From Baseline in CD4+ T-Cell Count
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Participants Receiving VH3810109 Plus rHuPH20 Plus CabotegravirExperimental Treatment3 Interventions
Group II: Participants Receiving VH3810109 Plus CabotegravirExperimental Treatment2 Interventions
Group III: Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART)Active Control1 Intervention
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1
Completed Phase 2
Completed Phase 1

Find a site

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
347 Previous Clinical Trials
464,112 Total Patients Enrolled

Media Library

Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05996471 — Phase 2

Frequently Asked Questions

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

Who is eligible to enroll in the clinical trial?

"This clinical trial seeks roughly 150 participants aged between 18 and 70, who have been diagnosed with human immunodeficiency virus infection."

Answered by AI

Is this research endeavor actively seeking participants?

"According to, recruitment for this medical study has concluded as the most recent changes were made on August 9th 2023. Nevertheless, there are still 456 other trials looking for patients at present."

Answered by AI

Does this investigation accommodate individuals aged thirty or older?

"This trial is open to patients aged between 18 and 70. Those under the age of 18 have access to 111 other studies, while those over 65 can select from 337 different trials."

Answered by AI

How many venues is the clinical trial being conducted in?

"Presently, this trial is deploying personnel to 39 medical centres for patient recruitment. Locations include Bakersfield, Los Angeles and Palm Springs as well as 36 other destinations. To reduce the burden of travelling far distances, it may be wise to pick a nearby centre if you choose to partake in the study."

Answered by AI

What is the Food and Drug Administration's stance on administering VH3810109 in combination with cabotegravir?

"Our team at Power gave VH3810109 Plus Cabotegravir a rating of 2 due to there being preliminary clinical evidence in its favour for safety, but none yet regarding efficacy."

Answered by AI
~100 spots leftby Oct 2024