Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed
2 other identifiers
interventional
618
13 countries
113
Brief Summary
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2016
Longer than P75 for phase_3
113 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 15, 2016
CompletedStudy Start
First participant enrolled
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2018
CompletedResults Posted
Study results publicly available
June 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedDecember 31, 2025
December 1, 2025
1.6 years
September 15, 2016
May 23, 2019
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
Number of participants with virologic failure endpoint (HIV-1 RNA\>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA \>=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.
Week 48
Secondary Outcomes (83)
Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48
Week 48
Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48
Week 48
Number of Participants With Confirmed Virologic Failure (CVF)
Weeks 8, 12, 20, 24, 32 and 40
Absolute Values for Plasma HIV-1 RNA at Week 48
Week 48
Change From Baseline Values for Plasma HIV-1 RNA
Baseline and Week 48
- +78 more secondary outcomes
Other Outcomes (1)
Number of Participants With Different Demographic Parameters for Inter-subject Variability
Upto Week 48
Study Arms (2)
CAB LA + RPV LA every 4 weeks
EXPERIMENTALEligible subjects receive Oral CAB 30 mg + RPV 25 mg once daily for four weeks, IM CAB LA 600 mg and RPV LA 900 mg for the first injection, and Week 4 onwards subjects will receive CAB LA (400 mg) + RPV LA (600 mg) injections every 4 weeks until withdrawal.
Current antiretroviral regimen
ACTIVE COMPARATOREligible subjects will continue their current anti-retroviral regimen (2 NRTIs plus an INI, NNRTI, or a PI) for 52 weeks. After 52 weeks subjects have the option to continue study participation by switching to CAB LA + RPV LA in the Extension Phase where they will follow the procedure of CAB LA + RPV LA arm.
Interventions
It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose
It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection
It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
Acceptable stable (initial or second) ARV regimens include 2 NRTIs plus: * INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen) * NNRTI (either the initial or second cART regimen) * Boosted PI (or atazanavir \[ATV\] unboosted) (either the initial or second PI-based cART regimen)
It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat
Eligibility Criteria
You may qualify if:
- Aged 18 years or older (or ≥19 where required by local regulatory agencies), at the time of signing the informed consent.
- Must be on uninterrupted current regimen (either the initial or second 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 c/mL).
- Acceptable stable (initial or second) ARV regimens prior to Screening include 2 NRTIs plus: INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen);NNRTI (either the initial or second cART regimen);Boosted PI (or atazanavir \[ATV\] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability) The addition, removal, or switch of a drug(s) that has been used to treat HIV based on antiretroviral properties of the drug constitutes a change in ART with the following limited exceptions: Historical changes in formulations of ART drugs or booster drugs will not constitute a change in ART regimen if the data support similar exposures and efficacy, and the change must have been at least 3 months prior to Screening; Historical perinatal use of an NRTI when given in addition to an ongoing HAART will not be considered a change in ART regimen; A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.
- Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening;
- Plasma HIV-1 RNA \<50 c/mL at Screening;
- A female subjects is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (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. 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 enrolment.
- Reproductive potential and agrees to 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, and until from 30 days prior to the first dose of study medication throughout the study, and 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 subjects understand how to properly use these methods of contraception.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form. 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. Enrolment 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.
- All subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.
You may not qualify if:
- Within 6 months prior to Screening and after confirmed suppression to \<50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement ≥50 c/mL
- Within the 6 to 12 month window prior to Screening and after confirmed suppression to \<50 c/mL, any plasma HIV-1 RNA measurement \>200 c/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 c/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 ≥400 c/mL after initial suppression to \<50 c/mL while on first line HIV therapy regimen)
- Abacavir/dolutegravir/lamivudine, (ABC/DTG/3TC) as current ART regimen
- A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART
- Subjects who are currently participating in or anticipate to be selected for any other interventional study
- Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
- Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease \[CDC, 2014\], except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm\^3
- 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 subjects 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 subjects with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrolment 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 enrolment
- All subjects will be screened for syphilis (rapid plasma reagin \[RPR\]). Subjects with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Subjects with a serofast RPR result (persistence of a reactive nontreponemal syphilis test) despite history of adequate therapy and no evidence of re-exposure may enrol after consultation with the Medical Monitor. Subjects with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis
- Subjects who, in the investigator's judgment, pose a significant suicide risk. Subject's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk
- The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Pharmaceuticalscollaborator
- GlaxoSmithKlinecollaborator
- ViiV Healthcarelead
Study Sites (113)
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
Long Beach, California, 90813, 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
Denver, Colorado, 80246, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20007, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20009, 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, 32960, 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
Detroit, Michigan, 48202, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
GSK Investigational Site
Buffalo, New York, 14201, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7064, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, 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
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77098, 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, 1427, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, C1405CKC, Argentina
GSK Investigational Site
Rosario, 2000, Argentina
GSK Investigational Site
Darlinghurst, New South Wales, 2010, Australia
GSK Investigational Site
Sydney, New South Wales, 2010, Australia
GSK Investigational Site
Prahran, Victoria, 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, 75018, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Paris, 75571, France
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Saint-Denis, 93205, 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, 80335, Germany
GSK Investigational Site
Brescia, 25123, Italy
GSK Investigational Site
Milan, 20157, Italy
GSK Investigational Site
Guadalajara, 44280, Mexico
GSK Investigational Site
Kazan', 420061, Russia
GSK Investigational Site
Kemerovo, 650056, Russia
GSK Investigational Site
Krasnodar, 350015, Russia
GSK Investigational Site
Lipetsk, 398043, Russia
GSK Investigational Site
Moscow, 105275, 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, 9301, 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
Pretorai, 0087, South Africa
GSK Investigational Site
Winnie Mandela, 9400, 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 (7)
Swindells 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: 34261093BACKGROUNDElliot 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: 39052748DERIVEDChounta V, Byrnes HF, Henry-Szatkowski M, Browning D, Donatti C, Lambert J. Psychometric Validation of the Perception of Injection (PIN) Questionnaire Using Data From Two Phase III, Open-Label, Active-Controlled, Non-Inferiority Studies in People Living With HIV. Adv Ther. 2023 Dec;40(12):5300-5314. doi: 10.1007/s12325-023-02656-1. Epub 2023 Sep 30.
PMID: 37776478DERIVEDMoreno 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: 35508986DERIVEDRizzardini G, Overton ET, Orkin C, Swindells S, Arasteh K, Gorgolas Hernandez-Mora M, Pokrovsky V, Girard PM, Oka S, Andrade-Villanueva JF, Richmond GJ, Baumgarten A, Masia M, Latiff G, Griffith S, Harrington CM, Hudson KJ, St Clair M, Talarico CL, Patel P, Cutrell A, Van Eygen V, D'Amico R, Mrus JM, Wu S, Ford SL, Chow K, Roberts J, Wills A, Walters N, Vanveggel S, Van Solingen-Ristea R, Crauwels H, Smith KY, Spreen WR, Margolis DA. Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):498-506. doi: 10.1097/QAI.0000000000002466.
PMID: 33136751DERIVEDSwindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.
PMID: 32130809DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Reponse Center
- Organization
- GlaxoSmithKline
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2016
First Posted
November 1, 2016
Study Start
October 28, 2016
Primary Completion
May 29, 2018
Study Completion (Estimated)
December 31, 2029
Last Updated
December 31, 2025
Results First Posted
June 13, 2019
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below).
- 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 is available via the Clinical Study Data Request site.