Actively Recruiting
A Phase 3b Open Label Randomized Study Evaluating Injectable CAB LA + RPV LA Versus Oral ART in Participants With Detectable HIV-1 (CROWN)
Led by ViiV Healthcare · Updated on 2026-05-27
332
Participants Needed
89
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well a long-acting injectable antiretroviral therapy (ART) combining cabotegravir (CAB LA) and rilpivirine (RPV LA) works for people living with HIV-1 who still have detectable virus levels despite taking oral ART. This Phase 3b open-label study sponsored by ViiV Healthcare aims to assess the treatment's effectiveness, safety, tolerability, and patient experience compared to standard oral ART. Participants in the study will receive initial injections of CAB LA and RPV LA at Day 1 and Month 1, followed by maintenance injections every two months for up to 24 months. They will continue their current oral ART regimen for approximately six months, including a final dose at the first injection visit. The study includes a randomized design with one group receiving the injectable treatment and another continuing oral ART as a control. During the study, participants will be monitored regularly to assess viral suppression and treatment response. Researchers will measure the number of participants achieving virologic suppression at Month 6, time to viral suppression, treatment discontinuations, and any treatment-emergent drug resistance or adverse events up to 24 months. The study will also gather patient feedback on their treatment experience and safety outcomes throughout the trial period.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 12 years or older and weigh at least 35 kg at consent
- Documented HIV-1 infection confirmed by licensed tests
- Plasma HIV-1 RNA between >1,000 and <100,000 copies/mL at screening
- Evidence of insufficient response to current oral ART within 18 months prior to study entry
- Willing to continue current oral ART regimen until about one week after Month 6 visit
- Negative pregnancy test for persons of childbearing potential at screening and Day 1
- Able to provide informed consent or assent (with parental/legal guardian consent for adolescents)
You will not qualify if you...
- Known HIV-1 subtype A6 infection
- Pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
- Unstable liver disease, cirrhosis, or significant liver abnormalities
- Co-infection with Hepatitis B without appropriate therapy or current Hepatitis C treatment
- High risk of seizures or poorly controlled seizure disorder
- History of sensitivity or allergy to study medications or related drugs
- Significant suicidality risk or mental/physical conditions interfering with study compliance
- Prior use of cabotegravir (CAB)
- Need for chronic anticoagulants or medications causing Torsades de Pointes
- Recent treatment with HIV immunotherapeutic vaccine or certain therapies (radiation, chemotherapy, immunomodulators)
- Use of experimental drugs or vaccines recently
- Concurrent participation in other interventional studies
- Viral drug resistance to INSTIs or NNRTIs
- Severe laboratory abnormalities or kidney function below threshold
- Unwillingness or inability to receive gluteal injections
- Presence of gluteal implants, tattoos, or dermatological conditions at injection sites
- Recent substance use disorder affecting safety
- Adolescents who are wards of the state or government
AI-Screening
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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
Participants receive either injectable CAB LA + RPV LA with initial monthly injections followed by maintenance injections every 2 months or continue their current oral ART regimen as part of the study treatment.
Initial injection visits at Day 1 and Month 1, then injections every 2 months for up to 24 months; oral ART participants continue their medication for 6 months
Trial Site Locations
Total: 89 locations
1
GSK Investigational Site
Birmingham, Alabama, United States, 35222
Actively Recruiting
2
GSK Investigational Site
Beverly Hills, California, United States, 90211
Withdrawn
3
GSK Investigational Site
Los Angeles, California, United States, 90035
Actively Recruiting
4
GSK Investigational Site
Los Angeles, California, United States, 90036
Actively Recruiting
5
GSK Investigational Site
Los Angeles, California, United States, 90069
Actively Recruiting
6
GSK Investigational Site
Aurora, Colorado, United States, 80045
Actively Recruiting
7
GSK Investigational Site
Denver, Colorado, United States, 80204
Actively Recruiting
8
GSK Investigational Site
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
GSK Investigational Site
Newark, Delaware, United States, 19711
Actively Recruiting
10
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20017
Actively Recruiting
11
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Actively Recruiting
12
GSK Investigational Site
Miami, Florida, United States, 33136
Actively Recruiting
13
GSK Investigational Site
Sarasota, Florida, United States, 34237
Actively Recruiting
14
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Actively Recruiting
15
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Actively Recruiting
16
GSK Investigational Site
Decatur, Georgia, United States, 30033
Actively Recruiting
17
GSK Investigational Site
Macon, Georgia, United States, 31201
Actively Recruiting
18
GSK Investigational Site
Chicago, Illinois, United States, 60611
Actively Recruiting
19
GSK Investigational Site
Chicago, Illinois, United States, 60613
Actively Recruiting
20
GSK Investigational Site
Chicago, Illinois, United States, 60637
Actively Recruiting
21
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Actively Recruiting
22
GSK Investigational Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
23
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Completed
24
GSK Investigational Site
Berkley, Michigan, United States, 48072
Completed
25
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Actively Recruiting
26
GSK Investigational Site
St Louis, Missouri, United States, 63110
Actively Recruiting
27
GSK Investigational Site
Newark, New Jersey, United States, 07102
Actively Recruiting
28
GSK Investigational Site
Hawthorne, New York, United States, 10532
Actively Recruiting
29
GSK Investigational Site
New York, New York, United States, 10010
Actively Recruiting
30
GSK Investigational Site
New York, New York, United States, 10032
Actively Recruiting
31
GSK Investigational Site
The Bronx, New York, United States, 10467
Actively Recruiting
32
GSK Investigational Site
The Bronx, New York, United States, 10468
Actively Recruiting
33
GSK Investigational Site
Greensboro, North Carolina, United States, 27401-1209
Actively Recruiting
34
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
Actively Recruiting
35
GSK Investigational Site
Columbus, Ohio, United States, 43210
Actively Recruiting
36
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
37
GSK Investigational Site
Dallas, Texas, United States, 75246
Actively Recruiting
38
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
39
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
40
GSK Investigational Site
Seattle, Washington, United States, 98104
Actively Recruiting
41
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53212
Actively Recruiting
42
GSK Investigational Site
Buenos Aires, Argentina, 1023
Actively Recruiting
43
GSK Investigational Site
Buenos Aires, Argentina, 1427
Actively Recruiting
44
GSK Investigational Site
Buenos Aires, Argentina, C1425AGC
Actively Recruiting
45
GSK Investigational Site
Capital Federal, Argentina, C1181ACH
Actively Recruiting
46
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, C1405CKC
Actively Recruiting
47
GSK Investigational Site
Córdoba, Argentina, X5000JJS
Actively Recruiting
48
GSK Investigational Site
Rosario, Argentina, S2000PBJ
Actively Recruiting
49
GSK Investigational Site
Antwerp, Belgium, 2000
Actively Recruiting
50
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Withdrawn
51
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
Completed
52
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
53
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany, 50674
Actively Recruiting
54
GSK Investigational Site
Berlin, Germany, 10439
Actively Recruiting
55
GSK Investigational Site
Cologne, Germany, 50668
Actively Recruiting
56
GSK Investigational Site
Düsseldorf, Germany, 40225
Actively Recruiting
57
GSK Investigational Site
Frankfurt, Germany, 60596
Actively Recruiting
58
GSK Investigational Site
Bari, Italy
Actively Recruiting
59
GSK Investigational Site
Bergamo, Italy, 24127
Actively Recruiting
60
GSK Investigational Site
Milan, Italy, 20127
Actively Recruiting
61
GSK Investigational Site
Milan, Italy, 20142
Actively Recruiting
62
GSK Investigational Site
Roma, Italy, 00149
Actively Recruiting
63
GSK Investigational Site
Porto, Portugal, 4099-001
Actively Recruiting
64
GSK Investigational Site
Porto, Portugal, 4200-319
Actively Recruiting
65
GSK Investigational Site
San Juan, Puerto Rico, 00909
Withdrawn
66
GSK Investigational Site
Barcelona, Spain, 08026
Actively Recruiting
67
GSK Investigational Site
Barcelona, Spain, 08035
Actively Recruiting
68
GSK Investigational Site
Barcelona, Spain, 08036
Actively Recruiting
69
GSK Investigational Site
Barcelona, Spain, 08907
Actively Recruiting
70
GSK Investigational Site
Barcelona, Spain, 8017
Actively Recruiting
71
GSK Investigational Site
Bilbao, Spain, 48013
Actively Recruiting
72
GSK Investigational Site
Cadiz, Spain, 11510
Actively Recruiting
73
GSK Investigational Site
Córdoba, Spain, 14004
Actively Recruiting
74
GSK Investigational Site
Madrid, Spain, 28006
Actively Recruiting
75
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
76
GSK Investigational Site
Madrid, Spain, 28020
Actively Recruiting
77
GSK Investigational Site
Madrid, Spain, 28031
Actively Recruiting
78
GSK Investigational Site
Madrid, Spain, 28034
Actively Recruiting
79
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
80
GSK Investigational Site
Madrid, Spain, 28041
Actively Recruiting
81
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
82
GSK Investigational Site
Málaga, Spain, 29010
Completed
83
GSK Investigational Site
Málaga, Spain, 29530
Actively Recruiting
84
GSK Investigational Site
Murcia, Spain, 30120
Actively Recruiting
85
GSK Investigational Site
Palma de Mallorca, Spain, 07120
Actively Recruiting
86
GSK Investigational Site
Sabadell Barcelona, Spain, 08208
Actively Recruiting
87
GSK Investigational Site
Seville, Spain, 41013
Actively Recruiting
88
GSK Investigational Site
Vigo Pontevedra, Spain, 36312
Actively Recruiting
89
GSK Investigational Site
Zaragoza, Spain, 50009
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
2
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