HIV patients may ditch daily pills for monthly shots

NCT ID NCT02938520

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

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether people with HIV who are already well-controlled on daily pills can switch to a monthly injection of two drugs (cabotegravir and rilpivirine) and stay just as healthy. About 630 adults whose virus is suppressed on a standard three-drug pill regimen will either continue their daily pills or switch to the monthly shots. The goal is to see if the injections are as good at keeping the virus undetectable 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 (injectable long-acting formulation)
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 on treatment and maintain viral suppression.
What could go wrong: This is a Phase 3 trial, but the injections may cause injection-site reactions or fail to suppress the virus in some people. Long-term safety and effectiveness beyond 48 weeks are still being studied.

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

631 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: - HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent. - HIV-1 infection as documented by Screening plasma HIV-1 RNA \>=1000 c/mL; - Antiretroviral-naive (\<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary. - Female Participants: A female participant is eligible to participate if she is not pregnant at Screening and first day of Induction Phase (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test), 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 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, 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 participants understand how to properly use these methods of contraception. All participants in the study should be counseled 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. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. - In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: - Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study. - Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current cluster of differentiation4+ (CD4+) cell count \<200 cells/ cubic millimeter (mm\^3) are not exclusionary. - Participants with known moderate to severe hepatic impairment. - Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. - Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant 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. - Participant who, in the investigator's judgment, poses a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. - The participant 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 dioxyribose nucleic acid (DNA) as follows: Participants positive for HBsAg are excluded; Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not 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; participants who are anticipated to require HCV treatment prior to Week 48 of the Maintenance Phase must be excluded. HCV treatment on study may be permitted post Week 48, following consultation with the Medical Monitor. Participants 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, HCV is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on participants 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 is inconclusive, the Fib-4 score will be used to verify eligibility. A 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 \[square root of ALT\]). - Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), 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. - All participants will be screened for syphilis (rapid plasma reagin \[RPR\]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis. - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrollment. - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the participant 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 pharmacokinetic sampling (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. - Current or anticipated need for chronic anti-coagulation. - Alanine aminotransferase (ALT) \>=3 times upper limit normal (ULN). - 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. - Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP). - Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; tuberculosis (TB) therapy, with the exception of treatment of latent TB with isoniazid; Immunomodulators that alter immune responses (such as chronic systemic corticosteroids, interleukins, or interferons). Note: Participants using short-term (e.g. =\<21 day) systemic corticosteroid treatment, topical, inhaled or intranasal corticosteroids are eligible for enrollment. - 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 the first dose of IP. - Use of medications which are associated with Torsades de Pointes - Any evidence of primary resistance to non-nuclease reverse transcriptase inhibitors (NNRTIs) (except for K103N which is allowed), or any known resistance to INIs from historical resistance test results. Note: re-tests of Screening genotypes are allowed only at the discretion of the study virologist. - Participants who are HLA-B\*5701 positive and are unable to use an nuclease reverse transcriptase inhibitors (NRTI) backbone that does not contain abacavir (participants who are HLA-B\*5701 positive may be enrolled if they use a NRTI backbone that does not contain abacavir; HLA-B\*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not possible). - 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 participant's participation in the study of an investigational compound. - Participant has estimated creatinine clearance \<50 mL/min/1.73m\^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. - Participants who are currently participating in or anticipate to be selected for any other interventional study.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

HIV infections

Contacts and locations

Locations

GSK Investigational Site

Birmingham, Alabama, 35294, 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, 90019, United States
GSK Investigational Site

Los Angeles, California, 90027, United States
GSK Investigational Site

San Francisco, California, 94109, United States
GSK Investigational Site

Aurora, Colorado, 80045, United States
GSK Investigational Site

Washington D.C., District of Columbia, 20005, United States
GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site

Orlando, Florida, 32806, United States
GSK Investigational Site

Atlanta, Georgia, 30312, United States
GSK Investigational Site

Augusta, Georgia, 30912-3130, United States
GSK Investigational Site

Macon, Georgia, 31201, United States
GSK Investigational Site

Indianapolis, Indiana, 46202, United States
GSK Investigational Site

Minneapolis, Minnesota, 55415, United States
GSK Investigational Site

Omaha, Nebraska, 68198, United States
GSK Investigational Site

Camden, New Jersey, 08103, United States
GSK Investigational Site

New York, New York, 10029, United States
GSK Investigational Site

Providence, Rhode Island, 02904, 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

Longview, Texas, 75605, United States
GSK Investigational Site

Lynchburg, Virginia, 24501, United States
GSK Investigational Site

Vancouver, British Columbia, V6Z 2C7, Canada
GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site

Toronto, Ontario, M5B 1W8, Canada
GSK Investigational Site

Toronto, Ontario, M5G 1K2, Canada
GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada
GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada
GSK Investigational Site

Bobigny, 93009, France
GSK Investigational Site

Lyon, 69437, France
GSK Investigational Site

Marseille, 13003, 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

Paris, 75970, 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, 80336, Germany
GSK Investigational Site

München, 80337, Germany
GSK Investigational Site

Brescia, 25123, Italy
GSK Investigational Site

Milan, 20127, Italy
GSK Investigational Site

Milan, 20157, Italy
GSK Investigational Site

Monza MB, 20900, Italy
GSK Investigational Site

Roma, 00149, Italy
GSK Investigational Site

Aichi, 460-0001, Japan
GSK Investigational Site

Osaka, 540-0006, Japan
GSK Investigational Site

Tokyo, 162-8655, Japan
GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site

Groningen, 9713 GZ, Netherlands
GSK Investigational Site

Rotterdam, 3079 DZ, Netherlands
GSK Investigational Site

Utrecht, 3584 CX, Netherlands
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, 115035, Russia
GSK Investigational Site

Oryol, 302040, Russia
GSK Investigational Site

Saint Petersburg, 190020, 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, 4052, South Africa
GSK Investigational Site

Durban, 4091, South Africa
GSK Investigational Site

Johannesburg, 2113, South Africa
GSK Investigational Site

Middelburg, 1055, South Africa
GSK Investigational Site

Pretoria, 0087, South Africa
GSK Investigational Site

Winnie Mandela, 9400, South Africa
GSK Investigational Site

A Coruña, 15006, Spain
GSK Investigational Site

Barcelona, 08025, Spain
GSK Investigational Site

Barcelona, 08907, Spain
GSK Investigational Site

Bilbao, 48013, Spain
GSK Investigational Site

Elche Alicante, 03203, Spain
GSK Investigational Site

Ferrol, 15405, Spain
GSK Investigational Site

Granada, 18016, Spain
GSK Investigational Site

La Laguna Santa Cruz, 38320, Spain
GSK Investigational Site

Madrid, 28040, Spain
GSK Investigational Site

Madrid, 28041, Spain
GSK Investigational Site

Madrid, 28046, Spain
GSK Investigational Site

Murcia, 30003, Spain
GSK Investigational Site

Murcia, 30120, Spain
GSK Investigational Site

Palma de Mallorca, 07010, Spain
GSK Investigational Site

Palma de Mallorca, 07198, Spain
GSK Investigational Site

San SebastiAn de Los Rey, 28702, Spain
GSK Investigational Site

Santa Cruz de Tenerife, 38010, Spain
GSK Investigational Site

Santander, 39008, Spain
GSK Investigational Site

Birmingham, B9 5SS, United Kingdom
GSK Investigational Site

Coventry, CV1 4FS, United Kingdom
GSK Investigational Site

Leeds Yorkshire, LS1 3EX, United Kingdom
GSK Investigational Site

London, E1 1BB, United Kingdom
GSK Investigational Site

London, NW3 2QG, United Kingdom
GSK Investigational Site

London, W2 1NY, United Kingdom
GSK Investigational Site

London, WC1E 6JB, United Kingdom

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