HIV patients may ditch daily pills for monthly shots in landmark trial

NCT ID NCT02951052

Disease control Sponsor: ViiV Healthcare Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether switching from daily HIV pills to monthly injections of cabotegravir and rilpivirine can keep the virus suppressed in adults with HIV. About 618 participants who are already virally suppressed will either stay on their current pills or switch to the shots. The goal is to see if the shots work just as well as daily pills over 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: cabotegravir and rilpivirine (as a monthly injection)
What this could lead to: If successful, this could offer people with HIV a convenient monthly injection instead of daily pills, making it easier to stay suppressed.
What could go wrong: This is a non-inferiority trial, so it aims to show the shots are not worse than pills, not necessarily better. Some people may prefer pills, and injection site reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

618 people

The number who actually took part.

Started

Oct 2016

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. 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. 2. 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. Exclusion Criteria: * 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 * Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:•Subjects positive for HBsAg are excluded; * Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded * Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted post Week 48, following consultation with the medical monitor) Subjects with HCV co-infection will be allowed entry into phase 3 studies if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on subjects with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility: Fib-4 score \> 3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula:( Age x AST ) / ( Platelets x ( sqr \[ ALT \]) * Unstable liver disease (as defined by any of the following: presence of ascites,encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices,or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment) * History of liver cirrhosis with or without hepatitis viral co-infection. * Ongoing or clinically relevant pancreatitis * Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomization * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the subject unable to receive study medication * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled * Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325mg). * Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International AIDS Society \[IAS\]-USA, 2015) by any historical resistance test result. * Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result * Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound * Subject has estimated creatine clearance \<50mL/min per 1.73m\^2 via CKDEPI Method * Alanine aminotransferase (ALT) ≥3 × ULN Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study; * Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid,INH); anti-coagulation agents; Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Subjects using short term (e.g. ≤21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening * Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1 * Use of medications which are associated with Torsade de Pointes. * Current or prior history of etravirine (ETR) * Current use of tipranavir/ritonavir or fosamprenavir/ritonavir * Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections Infection, human immunodeficiency virus

Contacts and locations

Locations

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 Buenos Aires, 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

Guadajalara, 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

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