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
A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed
2 other identifiers
interventional
1,049
13 countries
118
Brief Summary
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Oct 2017
Longer than P75 for phase_3 hiv-infections
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2017
CompletedFirst Posted
Study publicly available on registry
October 2, 2017
CompletedStudy Start
First participant enrolled
October 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2019
CompletedResults Posted
Study results publicly available
June 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedAugust 22, 2025
August 1, 2025
1.6 years
September 26, 2017
May 26, 2020
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
Week 48
Secondary Outcomes (45)
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 48
Week 48
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using FDA Snapshot Algorithm at Week 24
Week 24
Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) Through Weeks 24 and 48
Weeks 24 and 48
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm at Week 24
Weeks 24
Absolute Values for HIV-1 RNA at Week 48
Weeks 48
- +40 more secondary outcomes
Other Outcomes (2)
Number of Participants With Different Demographic Parameters for Inter-participant Variability
Up to Week 48
Number of Participants With Different Demographic Parameters for Intra-participant Variability
Up to Week 48
Study Arms (4)
Subjects in group 1 receiving study treatment once in 4 weeks
EXPERIMENTALGroup 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q4W via intramuscular (IM) route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.
Subjects in group 1 receiving study treatment once in 8 weeks
EXPERIMENTALGroup 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q8W via IM route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.
Subjects in group 2 receiving study treatment once in 4 weeks
EXPERIMENTALGroup 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to continue CAB LA plus RPV LA Q4W administration via IM route.
Subjects in group 2 receiving study treatment once in 8 weeks
EXPERIMENTALGroup 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to receive CAB LA plus RPV LA Q8W via IM route.
Interventions
CAB tablets are white to almost white oval shaped film coated 30 mg tablets for oral administration. CAB tablets are to be stored up to 30 degree Celsius and protected from moisture.
RPV tablets are 25 mg tablets that are off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". RPV tablets should be stored at 25 degree Celsius (excursions permitted to 15 degree-30 degree Celsius) and protected from light.
CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 mg/mL of GSK1265744 as free acid for administration by IM injection. CAB LA injectable suspension is to be stored at up to 30 degree Celsius and should not be frozen.
RPV LA injectable suspension is a sterile white suspension containing 300 mg/mL of RPV as the free base for administration by IM injection. RPV LA injectable suspension should be kept in the outer package and stored at 2-8 degree Celsius and should not be frozen. RPV LA should also be protected from light.
Eligibility Criteria
You may qualify if:
- Subjects who will be able to understand and comply with protocol requirements, instructions, and restrictions.
- Understand the long term commitment to the study and be likely to complete the study as planned
- Be considered as an appropriate candidate for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).
- Aged 18 years or older (or \>=19 where required by local regulatory agencies), at the time of signing the informed consent.
- A female is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies:
- Non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; Documented Bilateral Oophorectomy.
- Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.
- Capable of giving signed informed consent. Eligible subjects or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of subjects who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
- Subjects enrolled in France must be affiliated to, or a beneficiary of, a social security category.
- Subjects receiving oral SOC treatment for HIV-1 (not participating in ATLAS Trial) must be on uninterrupted current regimen \[either the initial or second anti-retroviral (ARV) regimen\] for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA \>=400 copies/mL).
- For subjects receiving oral SOC treatment for HIV-1 (not participating in ATLAS Trial) Documented evidence of at least two plasma HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening: one within the 6 to 12-month window, and one within 6 months prior to Screening.
- For subjects receiving oral SOC treatment for HIV-1 (not participating in ATLAS Trial): Plasma HIV-1 RNA \<50 copies/mL at Screening
- Subjects transitioning from 201585 (ATLAS) must have been on CAB LA 400 milligram (mg) + RPV LA 600 mg Q4W or "Current ART" regimen through at minimum Week 52 of the ATLAS study as per ATLAS protocol dosing requirements and until Day 1 of the ATLAS-2M study. Any disruptions in dosing during ATLAS must be discussed with the Medical Monitor for a final determination of eligibility.
- Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 152 weeks while on the ATLAS-2M study.
- +1 more criteria
You may not qualify if:
- For subjects not transitioning from 201585 (ATLAS):
- Within 6 months prior to Screening, any plasma HIV-1 RNA measurement \>=50 copies/mL
- Within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement \>200 copies/mL, or 2 or more plasma HIV-1 RNA measurements \>=50 copies/mL
- Any drug holiday during the window between initiating first HIV ART and 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
- Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement \>=200 copies/mL after initial suppression to \<50 copies/mL while on first line HIV therapy regimen)
- A history of use of any regimen consisting of only mono or dual HIV-1 therapy (even if only for peri-partum treatment). Subjects who are currently participating in or anticipate to be selected for any other interventional study with the exception of the 201585 (ATLAS) study.
- For Subjects transitioning from 201585 (ATLAS):
- During participation in ATLAS, consecutive (2 or more sequential) plasma HIV-1 RNA measurements \>=50 copies/mL
- During participation in ATLAS, any HIV-1 RNA measurement \>=200 copies/mL
- More than two total measurements of plasma HIV-1 RNA \>=50 c/mL during participation in the ATLAS trial will require direct approval by the ATLAS-2M Medical Monitor and Study virologist for study participation.
- For all subjects:
- Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
- Subjects with moderate to severe hepatic impairment.
- Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject.
- Subjects determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment.
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Janssen Research & Development, LLCcollaborator
Study Sites (118)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Phoenix, Arizona, 85015, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Beverly Hills, California, 90211, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
Los Angeles, California, 90027, United States
GSK Investigational Site
Los Angeles, California, 90036, United States
GSK Investigational Site
Los Angeles, California, 90069, United States
GSK Investigational Site
Palm Springs, California, 92264, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
San Francisco, California, 94110, United States
GSK Investigational Site
San Francisco, California, 94118, United States
GSK Investigational Site
Torrance, California, 90502, United States
GSK Investigational Site
Denver, Colorado, 80246, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20005, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20007, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Ft. Pierce, Florida, 34982, United States
GSK Investigational Site
Sarasota, Florida, 34237, United States
GSK Investigational Site
Vero Beach, Florida, 32690, United States
GSK Investigational Site
Augusta, Georgia, 30912-3130, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Boston, Massachusetts, 02129, United States
GSK Investigational Site
Minneapolis, Minnesota, 55415, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
New York, New York, 10065, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Cincinnati, Ohio, 45267-0405, United States
GSK Investigational Site
Allentown, Pennsylvania, 18102, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77098, United States
GSK Investigational Site
Longview, Texas, 75605, United States
GSK Investigational Site
Annandale, Virginia, 22003, United States
GSK Investigational Site
Lynchburg, Virginia, 24501, United States
GSK Investigational Site
Buenos Aires, 1141, Argentina
GSK Investigational Site
Buenos Aires, C1202ABB, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, C1405CKC, Argentina
GSK Investigational Site
Rosario, S2000PBJ, Argentina
GSK Investigational Site
Darlinghurst, New South Wales, 2010, Australia
GSK Investigational Site
Sydney, New South Wales, 2010, Australia
GSK Investigational Site
Prahran, Prahran 3181, Australia
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Toronto, Ontario, M5G 1K2, Canada
GSK Investigational Site
Montreal, Quebec, H2L 4E9, Canada
GSK Investigational Site
Montreal, Quebec, H4A 3J1, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G2, Canada
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5, Canada
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Paris, 75012, France
GSK Investigational Site
Paris, 75013, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Saint-Denis, 93200, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Tourcoing, 59208, France
GSK Investigational Site
Berlin, 10439, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Bonn, 53127, Germany
GSK Investigational Site
Essen, 45122, Germany
GSK Investigational Site
Frankfurt, 60590, Germany
GSK Investigational Site
Frankfurt, 60596, Germany
GSK Investigational Site
Hamburg, 20146, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hanover, 30625, Germany
GSK Investigational Site
München, 80337, Germany
GSK Investigational Site
Brescia, 25123, Italy
GSK Investigational Site
Milan, 20157, Italy
GSK Investigational Site
Guadalajara, 44280, Mexico
GSK Investigational Site
Kazan', 420097, Russia
GSK Investigational Site
Kemerovo, 650056, Russia
GSK Investigational Site
Krasnodar, 350015, Russia
GSK Investigational Site
Lipetsk, 398043, Russia
GSK Investigational Site
Moscow, 115035, Russia
GSK Investigational Site
Oryol, 302040, Russia
GSK Investigational Site
Saint Petersburg, 190103, Russia
GSK Investigational Site
Saint Petersburg, 193167, Russia
GSK Investigational Site
Saint Petersburg, 196645, Russia
GSK Investigational Site
Saratov, 410009, Russia
GSK Investigational Site
Smolensk, 214006, Russia
GSK Investigational Site
Toliyatti, 445846, Russia
GSK Investigational Site
Yekaterinburg, 620102, Russia
GSK Investigational Site
Bloemfontein, 9300, South Africa
GSK Investigational Site
Cape Town, 7925, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Durban, 4052, South Africa
GSK Investigational Site
Johannesburg, 2113, South Africa
GSK Investigational Site
Middelburg, 1055, South Africa
GSK Investigational Site
Daegu, 41944, South Korea
GSK Investigational Site
Daejeon, 35015, South Korea
GSK Investigational Site
Pusan, 49241, South Korea
GSK Investigational Site
Seoul, 03722, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Córdoba, 14004, Spain
GSK Investigational Site
Elche Alicante, 03203, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41013, Spain
GSK Investigational Site
Valencia, 46014, Spain
GSK Investigational Site
Vigo Pontevedra, 36312, Spain
GSK Investigational Site
Gothenburg, SE-416 85, Sweden
GSK Investigational Site
Stockholm, SE-118 83, Sweden
GSK Investigational Site
Stockholm, SE-14186, Sweden
Related Publications (8)
Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, Garcia Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/S0140-6736(20)32666-0. Epub 2020 Dec 9.
PMID: 33308425BACKGROUNDOverton ET, Richmond G, Rizzardini G, Thalme A, Girard PM, Wong A, Porteiro N, Swindells S, Reynes J, Noe S, Harrington C, Espanol CM, Acuipil C, Aksar A, Wang Y, Ford SL, Crauwels H, van Eygen V, Van Solingen-Ristea R, Latham CL, Thiagarajah S, D'Amico R, Smith KY, Vandermeulen K, Spreen WR. Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study. Clin Infect Dis. 2023 May 3;76(9):1646-1654. doi: 10.1093/cid/ciad020.
PMID: 36660819BACKGROUNDElliot ER, Polli JW, Patel P, Garside L, Grove R, Barnett V, Roberts J, Byrapuneni S, Crauwels H, Ford SL, Van Solingen-Ristea R, Birmingham E, D'Amico R, Baugh B, van Wyk J. Efficacy, Safety, and Pharmacokinetics by Body Mass Index Category in Phase 3/3b Long-Acting Cabotegravir Plus Rilpivirine Trials. J Infect Dis. 2024 Jul 25;230(1):e34-e42. doi: 10.1093/infdis/jiad580.
PMID: 39052748DERIVEDMoreno S, Rivero A, Ventayol P, Falco V, Torralba M, Schroeder M, Neches V, Vallejo-Aparicio LA, Mackenzie I, Turner M, Harrison C. Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2 Months is Cost-Effective for the Treatment of HIV-1 in Spain. Infect Dis Ther. 2023 Aug;12(8):2039-2055. doi: 10.1007/s40121-023-00840-y. Epub 2023 Jul 14.
PMID: 37452174DERIVEDChounta V, Snedecor SJ, Wu S, Van de Velde N. Indirect comparison of 48-week efficacy and safety of long-acting cabotegravir and rilpivirine maintenance every 8 weeks with daily oral standard of care antiretroviral therapy in participants with virologically suppressed HIV-1-infection. BMC Infect Dis. 2022 May 4;22(1):428. doi: 10.1186/s12879-022-07243-3.
PMID: 35508986DERIVEDJaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.
PMID: 34648734DERIVEDSwindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.
PMID: 34261093DERIVEDChounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR. Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). Patient. 2021 Nov;14(6):849-862. doi: 10.1007/s40271-021-00524-0. Epub 2021 May 31.
PMID: 34056699DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- ViiV Healthcare
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This will be an open-label study and therefore no blinding is required
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2017
First Posted
October 2, 2017
Study Start
October 27, 2017
Primary Completion
June 6, 2019
Study Completion (Estimated)
December 31, 2029
Last Updated
August 22, 2025
Results First Posted
June 11, 2020
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.