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

ViiV Healthcare

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: VH4011499; Drug: VH4004280 Matching Placebo; Drug: VH4011499 Matching Placebo; Drug: VH4004280; Drug: Antiretroviral therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06039579

2023-505350-18-00 (Other Identifier)

218307

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 8 patient groups, including a placebo group

Part 1a: VH4004280 Dose Level 1

Experimental group

Description:

Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4004280

Part 1a: VH4004280 Dose Level 2

Experimental group

Description:

Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4004280

Part 2a: VH4004280 pre-specified dose

Experimental group

Description:

Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4004280

Matching placebo for VH4004280

Placebo Comparator group

Description:

Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4004280 Matching Placebo

Part 1b: VH4011499 Dose Level 1

Experimental group

Description:

Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4011499

Part 1b: VH4011499 Dose Level 2

Experimental group

Description:

Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4011499 Matching Placebo

Drug: VH4011499

Part 2b: VH4011499 pre-specified dose

Experimental group

Description:

Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy

Drug: VH4011499

Matching placebo for VH4011499

Placebo Comparator group

Description:

Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.

Treatment:

Drug: Antiretroviral therapy