← Back to Search

Antiviral

VH4004280/VH4011499 for HIV (CINNAMON Trial)

Phase 2
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
Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary
Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period
Must not have
Women who are breastfeeding or plan to become pregnant or breast feed during the study
Untreated syphilis infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and up to day 11

Summary

This trial is testing two drugs to see if they can treat HIV in those who haven't had treatment before.

Who is the study for?
This trial is for adults with HIV-1 who haven't had antiretroviral therapy but may have used oral PreP. They should be healthy otherwise, with a BMI of 18.5-31 kg/m^2, CD4+ count ≥200 cells/µL, and viral load ≥3000 copies/mL. Participants must agree to start standard HIV treatment after the study and use reliable birth control.
What is being tested?
The study tests the effects of two new drugs, VH4004280 and VH4011499, taken orally by themselves for 10 days in people who have never been treated for their HIV infection before. It aims to see how well these drugs reduce the virus's presence in the blood.
What are the potential side effects?
Potential side effects aren't specified here but could include typical reactions to antiviral medications such as nausea, headache, fatigue or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have HIV-1 and haven't received treatment for it, but I may have used oral PreP.
Select...
I am willing and able to start HIV treatment after the initial treatment period.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am breastfeeding or plan to become pregnant or breastfeed during the study.
Select...
I have an untreated syphilis infection.
Select...
I have cancer, but it's not spreading significantly.
Select...
I am currently taking medication that affects my immune system or fights HIV.
Select...
I do not have severe mental, liver, heart, stomach, or kidney conditions.
Select...
I have not taken any medication or received vaccines that are not allowed.
Select...
I have recently been diagnosed with HIV.
Select...
I have an advanced stage of an infectious disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and up to day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter)
Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4011499 (copies per milliliter)

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2b - Participants Receiving VH4011499 Dose 3Experimental Treatment1 Intervention
Group II: Part 2a - Participants Receiving VH4004280 Dose 3Experimental Treatment1 Intervention
Group III: Part 1b - Participants Receiving VH4011499 Dose 2Experimental Treatment1 Intervention
Group IV: Part 1b - Participants Receiving VH4011499 Dose 1Experimental Treatment1 Intervention
Group V: Part 1a - Participants Receiving VH4004280 Dose 2Experimental Treatment1 Intervention
Group VI: Part 1a - Participants Receiving VH4004280 Dose 1Experimental Treatment1 Intervention
Group VII: Part 2a - Participants Receiving VH4004280 Matching PlaceboPlacebo Group1 Intervention
Group VIII: Part 1b - Participants Receiving VH4011499 Matching PlaceboPlacebo Group1 Intervention
Group IX: Part 1a - Participants Receiving VH4004280 Matching PlaceboPlacebo Group1 Intervention
Group X: Part 2b - Participants Receiving VH4011499 Matching PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VH4004280
2021
Completed Phase 2
~120
VH4011499
2022
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
372 Previous Clinical Trials
470,044 Total Patients Enrolled
~22 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top