Actively Recruiting
A Phase 2b Randomized, Open-Label Study Evaluating Oral VH4524184 With Emtricitabine and Tenofovir Alafenamide in Adults with HIV-1 Who Have Not Received Treatment
Led by ViiV Healthcare · Updated on 2026-05-08
150
Participants Needed
113
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the medication VH4524184 for treating adults with HIV-1 who have never received treatment before. The study compares two doses of VH4524184, each combined with emtricitabine and tenofovir alafenamide (FTC/TAF), against a standard treatment of dolutegravir and lamivudine (DTG/3TC). This phase 2b trial aims to provide data on the long-term antiviral effects and appropriate dosing of VH4524184 for future studies. Participants are randomly assigned to receive either a low or high daily dose of VH4524184 combined with FTC/TAF for 12 months, or the standard DTG/3TC treatment daily for 24 months. Those on VH4524184 may continue with a selected dose plus FTC/TAF from 12 to 24 months. All medications are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will undergo regular assessments including blood tests to measure HIV-1 RNA levels and CD4+ T-cell counts, monitoring for side effects, and measuring drug concentrations in the blood. The primary outcome is the percentage of participants achieving HIV-1 RNA suppression below 50 copies/mL at 12 months. Safety and maintenance of viral suppression will also be tracked through month 24. The total participation can last up to two years, with ongoing evaluations to understand long-term treatment effects.
CONDITIONS
Brief Title
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at time of informed consent
- Screening CD4+ T-cell count greater than 200 cells/microlitre
- Documented HIV-1 infection with plasma HIV-1 RNA of at least 1000 copies/millilitre
- No prior antiretroviral treatment after HIV-1 diagnosis
- Body weight at least 50 kg for males assigned at birth, or at least 45 kg for females assigned at birth
- Body mass index (BMI) between 18.5 and 35.5 kg/m2 inclusive
- For females assigned at birth: not pregnant or breastfeeding, and either non-childbearing potential or using effective contraception with failure rate under 1%
- Ability to give signed informed consent
You will not qualify if you...
- Breastfeeding or planning to breastfeed during the study
- Acute HIV infection with recent symptoms or documented viremia without antibody production within 3 months
- Active CDC Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy
- Unstable liver disease or biliary abnormalities except Gilbert's syndrome or stable chronic liver disease
- History of cirrhosis with or without viral hepatitis co-infection
- Hepatitis C virus (HCV) co-infection
- HIV and hepatitis B virus (HBV) co-infection
- Uncontrolled malignancy; controlled malignancy may be included with agreement
- Any condition interfering with study compliance or safety as judged by investigator
- Conditions affecting absorption, metabolism, or ability to take oral medication
- Significant cardiovascular disease or history of cardiac events
- Use of protocol-prohibited medications without willingness to switch
- Sensitivity or allergy to study medications or components
- Need for chronic anticoagulation except low-dose aspirin or hereditary coagulation disorders
- Recent treatment with radiation, chemotherapy, immunosuppressants, or anti-HIV agents within specified timeframes
- Participation in another clinical study within 30 days prior to consent
- Known or suspected resistance mutations to integrase inhibitors or nucleoside reverse transcriptase inhibitors
- Creatinine clearance below 60 mL/min/1.73 m2
- Alanine transaminase (ALT) levels greater than three times the upper limit of normal
- Grade 4 laboratory abnormalities except specific exceptions
- Screening ECG showing prolonged QT interval beyond specified limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months depending on assigned treatment arm
Participants receive daily oral doses of study medications including VH4524184 combined with FTC/TAF or DTG plus 3TC for HIV-1 treatment.
Regular visits throughout treatment period
Trial Site Locations
Total: 113 locations
1
GSK Investigational Site
Bakersfield, California, United States, 93301
Actively Recruiting
2
GSK Investigational Site
Palm Springs, California, United States, 92262
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3
GSK Investigational Site
West Hollywood, California, United States, 90046
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4
GSK Investigational Site
Aurora, Colorado, United States, 80045
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5
GSK Investigational Site
New Haven, Connecticut, United States, 06501
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6
GSK Investigational Site
Ft. Pierce, Florida, United States, 34982
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7
GSK Investigational Site
Hollywood, Florida, United States, 33021
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8
GSK Investigational Site
Miami, Florida, United States, 33136
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9
GSK Investigational Site
Miami Gardens, Florida, United States, 33055
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10
GSK Investigational Site
Oakland Park, Florida, United States, 33334
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11
GSK Investigational Site
Orlando, Florida, United States, 32803
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12
GSK Investigational Site
Orlando, Florida, United States, 32803
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13
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
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14
GSK Investigational Site
Atlanta, Georgia, United States, 30308
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15
GSK Investigational Site
Macon, Georgia, United States, 31201
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16
GSK Investigational Site
Louisville, Kentucky, United States, 40202
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17
GSK Investigational Site
Columbia, Missouri, United States, 65212
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18
GSK Investigational Site
Kansas City, Missouri, United States, 64111
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19
GSK Investigational Site
Omaha, Nebraska, United States, 68106
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20
GSK Investigational Site
Newark, New Jersey, United States, 07102
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21
GSK Investigational Site
Albany, New York, United States, 12208
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22
GSK Investigational Site
Manhasset, New York, United States, 11030
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23
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
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24
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
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25
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
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26
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
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27
GSK Investigational Site
Bellaire, Texas, United States, 77401
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28
GSK Investigational Site
Dallas, Texas, United States, 75246
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29
GSK Investigational Site
Houston, Texas, United States, 77025
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30
GSK Investigational Site
Houston, Texas, United States, 77030
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31
GSK Investigational Site
Longview, Texas, United States, 75605
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32
GSK Investigational Site
Seattle, Washington, United States, 98104
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33
GSK Investigational Site
Buenos Aires, Argentina, 1023
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34
GSK Investigational Site
Buenos Aires, Argentina, 1427
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35
GSK Investigational Site
Buenos Aires, Argentina, C1425AGC
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36
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1002ABJ
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37
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, 1405
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38
GSK Investigational Site
Mar del Plata, Argentina, B7600FZO
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39
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000IHE
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40
GSK Investigational Site
Sydney, New South Wales, Australia, 2010
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41
GSK Investigational Site
Clayton, Victoria, Australia, 3168
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42
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
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43
GSK Investigational Site
Antwerp, Belgium, 2000
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44
GSK Investigational Site
Brussels, Belgium, 1000
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45
GSK Investigational Site
Ghent, Belgium, 9000
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46
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
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47
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
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48
GSK Investigational Site
Nantes, France, 44093
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49
GSK Investigational Site
Nîmes, France, 30029
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50
GSK Investigational Site
Paris, France, 75012
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51
GSK Investigational Site
Berlin, Germany, 10787
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52
GSK Investigational Site
Cologne, Germany, 50937
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53
GSK Investigational Site
Frankfurt, Germany, 60590
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54
GSK Investigational Site
Hamburg, Germany, 20146
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55
GSK Investigational Site
München, Germany, 80337
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56
GSK Investigational Site
Bergamo, Italy, 24127
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57
GSK Investigational Site
Milan, Italy, 20122
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58
GSK Investigational Site
Milan, Italy, 20127
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59
GSK Investigational Site
Milan, Italy, 20142
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60
GSK Investigational Site
Milan, Italy, 20157
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61
GSK Investigational Site
Palermo, Italy, 90127
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62
GSK Investigational Site
Roma, Italy, 00149
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63
GSK Investigational Site
Roma, Italy
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64
GSK Investigational Site
Fukuoka, Japan, 810-8563
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65
GSK Investigational Site
Kanagawa, Japan, 221-0855
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66
GSK Investigational Site
Okinawa, Japan, 901-2725
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67
GSK Investigational Site
Osaka, Japan, 534-0021
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68
GSK Investigational Site
Osaka, Japan, 540-0006
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69
GSK Investigational Site
Tokyo, Japan, 160-0023
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70
GSK Investigational Site
Tokyo, Japan, 162-8655
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71
GSK Investigational Site
Bydgoszcz, Poland, 85-030
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72
GSK Investigational Site
Gdansk, Poland, 80-405
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73
GSK Investigational Site
Gaia, Portugal, 4434-502
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74
GSK Investigational Site
Porto, Portugal, 4099-001
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75
GSK Investigational Site
Porto, Portugal, 4200-319
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76
GSK Investigational Site
A Coruña, Spain, 15006
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77
GSK Investigational Site
Alicante, Spain, 03010
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78
GSK Investigational Site
Almeira, Spain, 04009
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79
GSK Investigational Site
Badalona, Spain, 08916
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80
GSK Investigational Site
Barcelona, Spain, 08003
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81
GSK Investigational Site
Barcelona, Spain, 08036
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82
GSK Investigational Site
Barcelona, Spain, 08041
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83
GSK Investigational Site
Barcelona, Spain, 08097
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84
GSK Investigational Site
Barcelona, Spain, 08830
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85
GSK Investigational Site
Elche Alicante, Spain, 03203
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86
GSK Investigational Site
Getafe, Spain, 28905
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87
GSK Investigational Site
Granada, Spain, 18014
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88
GSK Investigational Site
HebrOn, Spain, 08035
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89
GSK Investigational Site
Madrid, Spain, 28006
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90
GSK Investigational Site
Madrid, Spain, 28007
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91
GSK Investigational Site
Madrid, Spain, 28020
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92
GSK Investigational Site
Madrid, Spain, 28031
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93
GSK Investigational Site
Madrid, Spain, 28040
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94
GSK Investigational Site
Madrid, Spain, 28041
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95
GSK Investigational Site
Madrid, Spain, 28046
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96
GSK Investigational Site
Marbella, Spain, 29603
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97
GSK Investigational Site
Málaga, Spain, 29010
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98
GSK Investigational Site
Murcia, Spain, 30003
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99
GSK Investigational Site
Palma de Mallorca, Spain, 07120
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100
GSK Investigational Site
Palma de Mallorca, Spain, 07198
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101
GSK Investigational Site
Sabadell Barcelona, Spain, 08208
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102
GSK Investigational Site
Santa Cruz de Tenerife, Spain, 38320
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103
GSK Investigational Site
Santander, Spain, 39011
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104
GSK Investigational Site
Seville, Spain, 41013
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105
GSK Investigational Site
Seville, Spain, 41014
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106
GSK Investigational Site
Valencia, Spain, 46014
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107
GSK Investigational Site
Valencia, Spain, 46026
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108
GSK Investigational Site
Vigo Pontevedra, Spain, 36312
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109
GSK Investigational Site
Zaragoza, Spain, 50009
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110
GSK Investigational Site
Kaohsiung City, Taiwan, 807
Actively Recruiting
111
GSK Investigational Site
Kaohsiung City, Taiwan, 813
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112
GSK Investigational Site
Taipei, Taiwan, 11217
Actively Recruiting
113
GSK Investigational Site
Taoyuan, Taiwan, 330
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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