Actively Recruiting
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
Led by ViiV Healthcare · Updated on 2026-05-08
150
Participants Needed
113
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
-
Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.
-
Screening CD4+ T-cell count >200 cells/microlitre (µL).
-
Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/millilitre (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.
-
Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
-
Body weight >=50.0 kilogram (kg) [(110 pounds (lbs)] for participants assigned male at birth and >=45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m^2 (inclusive - applies to males and females).
-
There are no contraceptive requirements for participants assigned male at birth.
-
Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding and one of the following conditions applies:
- Is a Participant of non-childbearing potential (PONCBP);OR Is a Participant of childbearing potential (POCBP) and using a contraceptive method with a failure rate of less than (<) 1% prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC/TAF FDC, or through the end of study (if in the control arm and never received VH4524184).
- A POCBP must have a negative pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. Participant with a positive serum test must be excluded.
-
Capable of giving signed informed consent.
You will not qualify if you...
- Participants who are breastfeeding or plan to breastfeed during the study.
- Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
- Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease [CDC 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary.
- Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- History of cirrhosis with or without viral hepatitis co-infection.
- Participants with HCV co-infection will be excluded from the study.
- Individuals who are co-infected with HIV and HBV will be excluded Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease.
- Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.
- Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
- Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication and normal gastrointestinal anatomy or motility or hepatic and/or renal function
- Clinically significant CV disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.
- Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
- Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
- Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
- Exposure to an approved vaccine within 14 days prior to Day 1.
- Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research
- Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and/or ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1.
- Creatinine clearance (eGFR) of <60 mL/min/1.73 m2 via CKD-EPI race neutral method [Delgado, 2021].
- ALT >3 times the upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
- Any Grade 4 laboratory abnormality at screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.
- Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 msec (males) or >470 msec (females); >480 msec for participants with bundle branch block.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
3
GSK Investigational Site
West Hollywood, California, United States, 90046
Actively Recruiting
4
GSK Investigational Site
Aurora, Colorado, United States, 80045
Actively Recruiting
5
GSK Investigational Site
New Haven, Connecticut, United States, 06501
Actively Recruiting
6
GSK Investigational Site
Ft. Pierce, Florida, United States, 34982
Actively Recruiting
7
GSK Investigational Site
Hollywood, Florida, United States, 33021
Actively Recruiting
8
GSK Investigational Site
Miami, Florida, United States, 33136
Actively Recruiting
9
GSK Investigational Site
Miami Gardens, Florida, United States, 33055
Actively Recruiting
10
GSK Investigational Site
Oakland Park, Florida, United States, 33334
Actively Recruiting
11
GSK Investigational Site
Orlando, Florida, United States, 32803
Actively Recruiting
12
GSK Investigational Site
Orlando, Florida, United States, 32803
Actively Recruiting
13
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Actively Recruiting
14
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Actively Recruiting
15
GSK Investigational Site
Macon, Georgia, United States, 31201
Actively Recruiting
16
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
17
GSK Investigational Site
Columbia, Missouri, United States, 65212
Actively Recruiting
18
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Actively Recruiting
19
GSK Investigational Site
Omaha, Nebraska, United States, 68106
Actively Recruiting
20
GSK Investigational Site
Newark, New Jersey, United States, 07102
Actively Recruiting
21
GSK Investigational Site
Albany, New York, United States, 12208
Actively Recruiting
22
GSK Investigational Site
Manhasset, New York, United States, 11030
Actively Recruiting
23
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
24
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Actively Recruiting
25
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Actively Recruiting
26
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
Actively Recruiting
27
GSK Investigational Site
Bellaire, Texas, United States, 77401
Actively Recruiting
28
GSK Investigational Site
Dallas, Texas, United States, 75246
Actively Recruiting
29
GSK Investigational Site
Houston, Texas, United States, 77025
Actively Recruiting
30
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
31
GSK Investigational Site
Longview, Texas, United States, 75605
Actively Recruiting
32
GSK Investigational Site
Seattle, Washington, United States, 98104
Actively Recruiting
33
GSK Investigational Site
Buenos Aires, Argentina, 1023
Actively Recruiting
34
GSK Investigational Site
Buenos Aires, Argentina, 1427
Actively Recruiting
35
GSK Investigational Site
Buenos Aires, Argentina, C1425AGC
Actively Recruiting
36
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1002ABJ
Actively Recruiting
37
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, 1405
Actively Recruiting
38
GSK Investigational Site
Mar del Plata, Argentina, B7600FZO
Actively Recruiting
39
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
40
GSK Investigational Site
Sydney, New South Wales, Australia, 2010
Actively Recruiting
41
GSK Investigational Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
42
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
43
GSK Investigational Site
Antwerp, Belgium, 2000
Actively Recruiting
44
GSK Investigational Site
Brussels, Belgium, 1000
Actively Recruiting
45
GSK Investigational Site
Ghent, Belgium, 9000
Actively Recruiting
46
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
Actively Recruiting
47
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
48
GSK Investigational Site
Nantes, France, 44093
Actively Recruiting
49
GSK Investigational Site
Nîmes, France, 30029
Actively Recruiting
50
GSK Investigational Site
Paris, France, 75012
Actively Recruiting
51
GSK Investigational Site
Berlin, Germany, 10787
Actively Recruiting
52
GSK Investigational Site
Cologne, Germany, 50937
Actively Recruiting
53
GSK Investigational Site
Frankfurt, Germany, 60590
Actively Recruiting
54
GSK Investigational Site
Hamburg, Germany, 20146
Actively Recruiting
55
GSK Investigational Site
München, Germany, 80337
Actively Recruiting
56
GSK Investigational Site
Bergamo, Italy, 24127
Actively Recruiting
57
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
58
GSK Investigational Site
Milan, Italy, 20127
Actively Recruiting
59
GSK Investigational Site
Milan, Italy, 20142
Actively Recruiting
60
GSK Investigational Site
Milan, Italy, 20157
Actively Recruiting
61
GSK Investigational Site
Palermo, Italy, 90127
Actively Recruiting
62
GSK Investigational Site
Roma, Italy, 00149
Actively Recruiting
63
GSK Investigational Site
Roma, Italy
Actively Recruiting
64
GSK Investigational Site
Fukuoka, Japan, 810-8563
Actively Recruiting
65
GSK Investigational Site
Kanagawa, Japan, 221-0855
Actively Recruiting
66
GSK Investigational Site
Okinawa, Japan, 901-2725
Actively Recruiting
67
GSK Investigational Site
Osaka, Japan, 534-0021
Actively Recruiting
68
GSK Investigational Site
Osaka, Japan, 540-0006
Actively Recruiting
69
GSK Investigational Site
Tokyo, Japan, 160-0023
Actively Recruiting
70
GSK Investigational Site
Tokyo, Japan, 162-8655
Actively Recruiting
71
GSK Investigational Site
Bydgoszcz, Poland, 85-030
Actively Recruiting
72
GSK Investigational Site
Gdansk, Poland, 80-405
Actively Recruiting
73
GSK Investigational Site
Gaia, Portugal, 4434-502
Actively Recruiting
74
GSK Investigational Site
Porto, Portugal, 4099-001
Actively Recruiting
75
GSK Investigational Site
Porto, Portugal, 4200-319
Actively Recruiting
76
GSK Investigational Site
A Coruña, Spain, 15006
Actively Recruiting
77
GSK Investigational Site
Alicante, Spain, 03010
Actively Recruiting
78
GSK Investigational Site
Almeira, Spain, 04009
Actively Recruiting
79
GSK Investigational Site
Badalona, Spain, 08916
Actively Recruiting
80
GSK Investigational Site
Barcelona, Spain, 08003
Actively Recruiting
81
GSK Investigational Site
Barcelona, Spain, 08036
Actively Recruiting
82
GSK Investigational Site
Barcelona, Spain, 08041
Actively Recruiting
83
GSK Investigational Site
Barcelona, Spain, 08097
Actively Recruiting
84
GSK Investigational Site
Barcelona, Spain, 08830
Actively Recruiting
85
GSK Investigational Site
Elche Alicante, Spain, 03203
Actively Recruiting
86
GSK Investigational Site
Getafe, Spain, 28905
Actively Recruiting
87
GSK Investigational Site
Granada, Spain, 18014
Actively Recruiting
88
GSK Investigational Site
HebrOn, Spain, 08035
Actively Recruiting
89
GSK Investigational Site
Madrid, Spain, 28006
Actively Recruiting
90
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
91
GSK Investigational Site
Madrid, Spain, 28020
Actively Recruiting
92
GSK Investigational Site
Madrid, Spain, 28031
Actively Recruiting
93
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
94
GSK Investigational Site
Madrid, Spain, 28041
Actively Recruiting
95
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
96
GSK Investigational Site
Marbella, Spain, 29603
Actively Recruiting
97
GSK Investigational Site
Málaga, Spain, 29010
Actively Recruiting
98
GSK Investigational Site
Murcia, Spain, 30003
Actively Recruiting
99
GSK Investigational Site
Palma de Mallorca, Spain, 07120
Actively Recruiting
100
GSK Investigational Site
Palma de Mallorca, Spain, 07198
Actively Recruiting
101
GSK Investigational Site
Sabadell Barcelona, Spain, 08208
Actively Recruiting
102
GSK Investigational Site
Santa Cruz de Tenerife, Spain, 38320
Actively Recruiting
103
GSK Investigational Site
Santander, Spain, 39011
Actively Recruiting
104
GSK Investigational Site
Seville, Spain, 41013
Actively Recruiting
105
GSK Investigational Site
Seville, Spain, 41014
Actively Recruiting
106
GSK Investigational Site
Valencia, Spain, 46014
Actively Recruiting
107
GSK Investigational Site
Valencia, Spain, 46026
Actively Recruiting
108
GSK Investigational Site
Vigo Pontevedra, Spain, 36312
Actively Recruiting
109
GSK Investigational Site
Zaragoza, Spain, 50009
Actively Recruiting
110
GSK Investigational Site
Kaohsiung City, Taiwan, 807
Actively Recruiting
111
GSK Investigational Site
Kaohsiung City, Taiwan, 813
Actively Recruiting
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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here