Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults (ATLAS-2M)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03299049 |
Recruitment Status :
Active, not recruiting
First Posted : October 2, 2017
Results First Posted : June 11, 2020
Last Update Posted : January 25, 2023
|
Sponsor:
ViiV Healthcare
Collaborator:
Janssen Research and Development
Information provided by (Responsible Party):
ViiV Healthcare
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: Cabotegravir Tablets Drug: Rilpivirine Tablets Drug: Cabotegravir Injectable Suspension Drug: Rilpivirine Injectable Suspension |
Enrollment | 1049 |
Participant Flow
Recruitment Details | This non-inferiority study evaluated antiviral activity of cabotegravir(CAB) long acting(LA) 600 milligrams(mg) + rilpivirine(RPV) LA 900 mg administered every 8 weeks(Q8W) compared with CAB LA 400 mg+RPV LA 600 mg administered every 4 weeks(Q4W) over a 48-week period in virologically suppressed human immunodeficiency type 1 infection participants. |
Pre-assignment Details | A total of 1049 eligible participants were randomized in a ratio of 1:1 to 1 of the 2 treatment arms in Maintenance Phase, of which 4 participants did not receive study treatment and 1045 participants were included in Intent to treat-Exposed Population. Results presented are based on Week 48 primary analysis. |
Arm/Group Title | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W |
---|---|---|
![]() |
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter. | Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1. |
Period Title: Overall Study | ||
Started | 522 | 523 |
Completed | 0 | 0 |
Not Completed | 522 | 523 |
Reason Not Completed | ||
On-going | 486 | 481 |
Withdrawal by Subject | 6 | 21 |
Physician Decision | 5 | 1 |
Lost to Follow-up | 2 | 0 |
Pregnancy | 1 | 3 |
Protocol Violation | 1 | 1 |
Lack of Efficacy | 9 | 3 |
Adverse Event | 12 | 13 |
Baseline Characteristics
Arm/Group Title | CAB LA + RPV LA Q8W | CAB LA + RPV LA Q4W | Total | |
---|---|---|---|---|
![]() |
Eligible participants transitioning from antiretroviral (ART) standard of care (SOC) therapy arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q8W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received intramuscular (IM) injections of CAB LA 600 mg and RPV LA 900 mg at Week 4b and Week 8 followed by injections Q8W thereafter. Participants transitioned from the CAB LA+RPV LA Q4W arm of ATLAS study received CAB LA 600 mg+RPV LA 900 mg intramuscular injections on Day 1, Week 8 and Q8W thereafter. | Eligible participants transitioning from ART SOC arm and CAB LA + RPV LA Q4W arm in the ATLAS (NCT02951052) study and randomized to receive CAB LA+RPV LA Q4W in the current study were administered oral therapy with CAB 30 mg + RPV 25 mg once daily at Day 1 for 4 weeks. Participants then received a loading dose of CAB LA 600 mg and RPV LA 900 mg IM injections at Week 4b followed maintenance injections of CAB LA 400 mg +RPV LA 600 mg Q4W thereafter. Participants transitioned from the Q4W arm of ATLAS study continued to receive CAB LA 400 mg+RPV LA 600 mg intramuscular injections administered Q4W from Day 1. | Total of all reporting groups | |
Overall Number of Baseline Participants | 522 | 523 | 1045 | |
![]() |
[Not Specified]
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 522 participants | 523 participants | 1045 participants | |
42.7 (11.16) | 42.3 (10.58) | 42.5 (10.87) | ||
Sex/Gender, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 522 participants | 523 participants | 1045 participants |
Sex at birth=Female | 137 | 143 | 280 | |
Sex at birth=Male | 385 | 380 | 765 | |
Sex/Gender, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 522 participants | 523 participants | 1045 participants | |
Reported gender=Female |
142 27.2%
|
146 27.9%
|
288 27.6%
|
|
Reported gender=Male |
380 72.8%
|
377 72.1%
|
757 72.4%
|
|
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 522 participants | 523 participants | 1045 participants |
American Indian (AI) or Alaska Native (AN) | 17 | 11 | 28 | |
Asian-Central/South Asian Heritage (H) | 1 | 1 | 2 | |
Asian-East Asian H | 20 | 12 | 32 | |
Asian-Japanese H | 0 | 2 | 2 | |
Asian-South East Asian (SEA) H | 8 | 7 | 15 | |
Black or African American (AA) | 101 | 90 | 191 | |
Native Hawaiian (NH) or other Pacific Islander | 3 | 1 | 4 | |
White-Arabic/North African H | 2 | 4 | 6 | |
White-White/Caucasian/European (EU) H | 368 | 388 | 756 | |
White-Mixed White Race | 0 | 1 | 1 | |
Multiple-AI/AN and Black/AA/White/Caucasian/EU H | 1 | 1 | 2 | |
Multiple-AI/AN and NH/Other Pacific Islander | 1 | 0 | 1 | |
Multiple-SEA H and White/Caucasian/ EU H | 0 | 1 | 1 | |
Multiple-Black/AA and White-Arabic/North African H | 0 | 1 | 1 | |
Multiple-Black/AA and White/Caucasian/EU H | 0 | 3 | 3 |