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

Sponsor

ViiV Healthcare (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039579

Collaborator

(none)

Enrollment

Locations

Arms

6.3

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: VH4004280 Drug: VH4011499 Drug: VH4004280 Matching Placebo Drug: VH4011499 Matching Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Phase 2a Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Investigational Capsid Inhibitor Monotherapy in HIV-1 Infected Treatment-Naïve Adults

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Mar 25, 2024

Anticipated Study Completion Date :

Mar 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1a - Participants Receiving VH4004280 Dose 1	Drug: VH4004280 VH4004280 will be administered.
Experimental: Part 1a - Participants Receiving VH4004280 Dose 2	Drug: VH4004280 VH4004280 will be administered.
Placebo Comparator: Part 1a - Participants Receiving VH4004280 Matching Placebo	Drug: VH4004280 Matching Placebo VH4004280 matching placebo will be administered.
Experimental: Part 1b - Participants Receiving VH4011499 Dose 1	Drug: VH4011499 VH4011499 will be administered.
Experimental: Part 1b - Participants Receiving VH4011499 Dose 2	Drug: VH4011499 VH4011499 will be administered.
Placebo Comparator: Part 1b - Participants Receiving VH4011499 Matching Placebo	Drug: VH4011499 Matching Placebo VH4011499 matching placebo will be administered.
Experimental: Part 2a - Participants Receiving VH4004280 Dose 3	Drug: VH4004280 VH4004280 will be administered.
Placebo Comparator: Part 2a - Participants Receiving VH4004280 Matching Placebo	Drug: VH4004280 Matching Placebo VH4004280 matching placebo will be administered.
Experimental: Part 2b - Participants Receiving VH4011499 Dose 3	Drug: VH4011499 VH4011499 will be administered.
Placebo Comparator: Part 2b - Participants Receiving VH4011499 Matching Placebo	Drug: VH4011499 Matching Placebo VH4011499 matching placebo will be administered.

Outcome Measures

Primary Outcome Measures

Maximum Change from Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) [Baseline (Day 1) and up to Day 11]

Secondary Outcome Measures

Number of Participants with Adverse Events (AE) as per Severity and AEs Leading to Study Treatment Discontinuation [Up to Day 39]
Change from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (Micromoles per Liter [umol/L]) [Baseline (Day 1) and up to Day 39]
Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International Units per Liter) [Baseline (Day 1) and up to Day 39]
Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (umol/L) [Baseline (Day 1) and up to Day 39]
Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: ALT, ALP, and AST (International Units per Liter) [Baseline (Day 1) and up to Day 39]
Maximum Observed Plasma Drug Concentration (Cmax) for VH4004280 [Up to Day 39]
Maximum Observed Plasma Drug Concentration (Cmax) for VH4011499 [Up to Day 39]
Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4004280 (Hours) [Up to Day 39]
Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4011499 (Hours) [Up to Day 39]
Plasma Concentrations of VH4004280 [At Day 11]
Plasma Concentrations of VH4011499 [At Day 11]
Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter) [Baseline (Day 1) and up to Day 11]
Plasma samples will be collected for quantitative analysis of HIV-1 RNA.
Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4011499 (copies per milliliter) [Baseline (Day 1) and up to Day 11]
Plasma samples will be collected for quantitative analysis of HIV-1 RNA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants who are overtly healthy (other than HIV-1 infection).
Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (≥)200 cells/microliter (µL).
Documented HIV-1 infection and Screening plasma HIV-1 RNA ≥3000 copies/milliliter (mL).
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.
Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m^2).
Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
Participants capable of giving signed informed consent.
Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period.

Exclusion Criteria:

Women who are breastfeeding or plan to become pregnant or breast feed during the study.
Participants with acute HIV infection.
Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease.
Untreated syphilis infection.
Ongoing malignancy other than certain localised malignancies.
Treatment with immunomodulating agents or any agent with known anti-HIV activity.
Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition.
Participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.
Participants having exclusionary electrocardiogram (ECG) findings.
Participants who have been exposed to any prohibited medication or vaccine.
Participant positive for hepatitis B or hepatitis C.
Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bakersfield	California	United States	93301
2	GSK Investigational Site	Palm Springs	California	United States	92262
3	GSK Investigational Site	Pasadena	California	United States	91101
4	GSK Investigational Site	DeLand	Florida	United States	32720
5	GSK Investigational Site	Vero Beach	Florida	United States	32960
6	GSK Investigational Site	Newark	New Jersey	United States	07102
7	GSK Investigational Site	Wilmington	North Carolina	United States	28401
8	GSK Investigational Site	Nashville	Tennessee	United States	37208
9	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1425AGC
10	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1405CKC
11	GSK Investigational Site	Ciudad de Buenos Aires	Buenos Aires	Argentina	C1202ABB
12	GSK Investigational Site	Buenos Aires		Argentina	1023
13	GSK Investigational Site	Edmonton	Alberta	Canada	T6G 2B7
14	GSK Investigational Site	Vancouver	British Columbia	Canada	V6Z 2T1
15	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 8L6
16	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2N2
17	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4P9
18	GSK Investigational Site	Marseille		France	13003
19	GSK Investigational Site	Nantes		France	44093
20	GSK Investigational Site	Paris		France	75012
21	GSK Investigational Site	Paris		France	75018
22	GSK Investigational Site	Tourcoing Cedex		France	59208
23	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen	Germany	40225
24	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50937
25	GSK Investigational Site	Hamburg		Germany	20146
26	GSK Investigational Site	Roma	Lazio	Italy	00149
27	GSK Investigational Site	Milano	Lombardia	Italy	20127
28	GSK Investigational Site	Milano	Lombardia	Italy	20157
29	GSK Investigational Site	Torino	Piemonte	Italy	10149
30	GSK Investigational Site	Guadalajara, Jalisco	Jalisco	Mexico	44160
31	GSK Investigational Site	Chihuahua		Mexico	31216
32	GSK Investigational Site	Merida		Mexico	97000
33	GSK Investigational Site	Mexico City		Mexico	06760
34	GSK Investigational Site	Badalona		Spain	08916
35	GSK Investigational Site	Barcelona		Spain	08035
36	GSK Investigational Site	L'Hospitalet De Llobregat. Barcelona		Spain	08907
37	GSK Investigational Site	Madrid		Spain	28034
38	GSK Investigational Site	Madrid		Spain	28040
39	GSK Investigational Site	Madrid		Spain	28046
40	GSK Investigational Site	Sevilla		Spain	41013
41	GSK Investigational Site	Liverpool.		United Kingdom	L7 8XP
42	GSK Investigational Site	London		United Kingdom	SE5 8RX
43	GSK Investigational Site	London		United Kingdom	WC1E 6LB