Proof of concept study of orally administered VH4004280 or VH4011499 in HIV-1 infected adults
Research type
Research Study
Full 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
IRAS ID
1008084
Contact name
Karen Grainger
Contact email
Sponsor organisation
ViiV Healthcare UK Limited
Eudract number
2023-505350-18
Research summary
Treatments for HIV-1 involve life-long therapy with antiretroviral (ARV) medications, which while effective, are often taken daily. Viiv are investigating two different potential ARV medications that could form part of a HIV-1 treatment that would be taken less frequently with the aim of improving patients’ quality of life though addressing treatment fatigue, treatment adherence and convenience
This clinical study will investigate efficacy, drug concentration and safety of VH400280 and VH4011499. Efficacy will be measured by reduction of HIV-1 virus quantity in the blood before treatment vs after treatment and safety by monitoring adverse events after oral administration of each compound for 10 days in adults with HIV 1 who are treatment naive (never treated before) aged ≥ 18YO.
Participants in the study, following provision of their consent, will initially undergo a screening visit to understand if they are eligible to take part in the study. Eligible patients will then return on Day 1 to receive either one of the ARV’s (VH400280 (Part 1a) VH4011499 (Part 1b)) at two different doses or a placebo. This study is double-blind, neither the doctors at the hospital or the patients will know what treatment they have received.
Patients will have assessments at the hospital at 5 separate visits over 10 days before returning on Day 11 at which time patients will receive an approved medication for HIV-1, patients will have visits to the hospital each week from Day 11 to Day 39. At the study visits patients will have blood samples taken to check that the patients HIV-1 virus concentrations fall and maintain a negligible level.
Patients will be initially recruited to part 1a before other patients are recruited into part 1b and there will an analysis of the data from each part 1 to determine if two other parts (Parts 2a and 2b) are necessary. Both, one or neither maybe carried out. Parts 2a and 2b will both randomise patients to receive either a 3rd dose of ARV or a placebo.REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0509
Date of REC Opinion
9 Nov 2023
REC opinion
Further Information Favourable Opinion