A Phase 2 interventional study of VH4524184 and Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets in HIV Infections, sponsored by ViiV Healthcare. Recruiting at 123 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by ViiV Healthcare · Phase 2, Interventional, and Treatment
This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.
4,259 studies on the registry are indexed under HIV Infections; 241 are open to participants now.
This study's planned enrollment of 186 is above the median of 83 across 3,252 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding and one of the following conditions applies:
Exclusion Criteria:
Participants receive a daily oral dose of VH4524184 Dose A (Low dose) in combination with a fixed dose containing FTC/TAF starting Day 1 until Month 12.
Drug: VH4524184 · Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
Participants receive a daily oral dose of VH4524184 Dose B (High dose) in combination with a fixed dose containing FTC / TAF beginning on Day 1 until the Month 12.
Drug: VH4524184 · Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
Participants receive a daily oral dose of DTG and 3TC (fixed dose combination) from Day 1 through Month 24.
Drug: Dolutegravir / Lamivudine (DTG/3TC)
Participants receive a selected dose of VH4524184, combined with FTC/TAF, orally once daily from to Month 12 to Month 24.
Drug: VH4524184 · Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
Oral tablet will be administered.
Oral table will be administered.
Also known as: DESCOVY
Oral tablets will be administered.
Also known as: DOVATO
Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot Methodology
Time frame: At Month 12
Percentage of Participants Maintaining Plasma HIV-1 RNA Suppression (<50 copies/mL) Based on Observed Laboratory Results
Time frame: Day 1 to Month 24
Percentage of Participants Achieving Plasma HIV-1 RNA Suppression (<50 copies/ml) as per FDA Snapshot Methodology
Time frame: Day 1 to Month 24
Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts
Blood samples will be collected for assessment of T-cells subsets (CD4+ T-cells count) by flow cytometry.
Time frame: Day 1 to Month 24
Number of Participants with Any Adverse Event (AE)
Time frame: Day 1 through the continuation period/end of study (approximately Month 36)
Number of Participants with AEs by Severity
The severity will be assessed using The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening and Grade 5 = Death.
Time frame: Day 1 through the continuation period/end of study (approximately Month 36)
Number of Participants with AEs Leading to Study Treatment Discontinuation
Time frame: Day 1 through the continuation period/end of study (approximately Month 36)
Plasma Concentration of VH4524184
Blood samples will be collected at indicated time point for PK analysis of VH4524184.
Time frame: Day 1 to Month 24
Showing the first 100 of 123 sites across 14 countries.
Plan to share: Yes — Sudy Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
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