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Antiviral

VH4004280/VH4011499 for HIV (CINNAMON Trial)

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and up to day 39

Awards & highlights

CINNAMON Trial 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.Check my eligibility

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.See study design

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.

CINNAMON 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.

CINNAMON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and up to day 39

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and up to day 39

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to day 39 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Change from Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA)

Secondary outcome measures

Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International Units per Liter)

Change from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (Micromoles per Liter [umol/L])

Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter)

+10 more

CINNAMON 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 1a - Participants Receiving VH4004280 Matching PlaceboPlacebo Group1 Intervention

Group VIII: Part 2a - Participants Receiving VH4004280 Matching PlaceboPlacebo Group1 Intervention

Group IX: Part 2b - Participants Receiving VH4011499 Matching PlaceboPlacebo Group1 Intervention

Group X: Part 1b - Participants Receiving VH4011499 Matching PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VH4004280

2021

Completed Phase 1

~80

VH4011499

2022

Completed Phase 1

~80

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

360 Previous Clinical Trials

468,537 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this research open to octogenarians?

"In order to comply with the trial's entry requirements, participants must be 18 or older and no more than 65 years old."

Answered by AI

Is it possible to join this trial as a participant?

"This research endeavour is seeking 42 individuals, aged 18-65 who have a documented human immunodeficiency virus infection. Other criteria necessary for the study include being in generally excellent health (aside from HIV test results)."

Answered by AI

To what extent does the administration of VH4004280 Dose 1 pose a risk to trial participants?

"Based on our team's assessment, the safety of Part 1a - Participants Receiving VH4004280 Dose 1 scored a 2 due to clinical evidence in support of its security, but without any data indicating efficacy."

Answered by AI

In which locations is the trial being conducted?

"Currently, 38 different medical sites are accepting participants for this trial. These locations span from Palm Springs to Pasadena and DeLand, with other options in between. To remove the need of extensive travel if you join, it is advisable that patients pick a site close to them."

Answered by AI

Is this investigation currently open to new participants?

"This clinical trial is no longer seeking applicants. It was first published on September 15th 2023, and last modified on the 12th of that same month. Even though this study is now closed to new patients, there are still 454 other medical trials accepting participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults

2023. "Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039579.