A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05917509 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2197002023-503893-19-00
• Study Type: interventional
• Target: 171
• Locations: 9 countries
• Sites: 47

Brief Summary

This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 \<50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.

Conditions

HIV Infections

Keywords

HIV-1; dolutegravir; lamivudine; cabotegravir; rilpivirine; Antiretroviral therapy (ART) - naïve; optional switch study; Long-acting; Fixed-dose combination; People living with HIV (PLHIV); Integrase inhibitor

Outcome Measures

Primary Outcomes (2)

• [DTG/3TC]: Time to Virologic Suppression (HIV-1 Ribonucleic Acid [RNA] <50 Copies per Millilitre [c/mL]) From Baseline (Day 1)

  Baseline (Day 1) up to Month 12

• [CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 11

  Month 11

Secondary Outcomes (51)

• [DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 12

  Month 12

• [DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL as Per Snapshot Algorithm

  Month 12

• [CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA >= 50 c/mL as Per Snapshot Algorithm

  Month 11

• Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Through Day of Choice

  Up to and including Day of Choice (approximately 20 weeks)

• [DTG/3TC]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL and <200 c/mL Over Time

  Up to and including Month 12

Study Arms (2)

Participants Receiving DTG/3TC Fixed Dose Combination (FDC)

EXPERIMENTAL

Drug: DTG/3TC

Participants Receiving CAB + RPV LA

EXPERIMENTAL

Drug: Cabotegravir (CAB) LA; Drug: Rilpivirine (RPV) LA

Interventions

DTG/3TC DRUG

DTG/3TC FDC will be administered as an oral once daily tablet.

Also known as: Dovato

Participants Receiving DTG/3TC Fixed Dose Combination (FDC)

Cabotegravir (CAB) LA DRUG

CAB LA will be administered as a gluteal intramuscular injection once every 2 months in combination with RPV LA.

Also known as: Vocabria

Participants Receiving CAB + RPV LA

Rilpivirine (RPV) LA DRUG

RPV LA will be administered as a gluteal intramuscular injection once every 2 months in combination with CAB LA.

Also known as: Rekambys

Participants Receiving CAB + RPV LA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with plasma HIV-1 RNA ≥1,000 c/mL at Screening.
• Antiretroviral-naïve participants (defined as no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) prior to enrolment.
• Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
• Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

You may not qualify if:

• Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
• Participants with history or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates study participation.
• Participants with ongoing or clinically relevant pancreatitis.
• Participants with Clinically significant cardiovascular disease, as defined by recent history (within the last 6 months) or current 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.
• Corrected QT (QTc) interval \>450 milliseconds (msec) (or QTc \>480 msec for participants with bundle branch block).
• Participants with hereditary coagulation and platelet disorders (e.g., haemophilia or von Willebrand Disease); or current or anticipated need for chronic anti-coagulation, with the exception of the use of low-dose acetylsalicylic acid (≤325 mg).
• Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
• Participants with 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, or decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment).
• Participants with history of liver cirrhosis with or without hepatitis viral co-infection.
• 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.
• Participants who, in the Investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
• Participants with signs and symptoms which, in the opinion of the Investigator, are suggestive of active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to enrolment.
• 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), and hepatitis B surface antibody (anti-HBs) as follows:
• Participants positive for HBsAg are excluded
• Participants negative for HBsAg and negative for anti-HBs but positive for anti-HBc are excluded only if HBV DNA is detected \[either detected below lower limit of quantification (LLOQ); detected above upper limit of quantification (ULOQ); or numerical value (i.e. between LLOQ and ULOQ)\];

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator
• PPD Development, LP: collaborator

Study Sites (47)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Pensacola, Florida, 32504, United States

Location

GSK Investigational Site

Berkley, Michigan, 48072, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

Henderson, Nevada, 89106, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28204, United States

Location

GSK Investigational Site

Huntersville, North Carolina, 28078, United States

Location

GSK Investigational Site

Beaumont, Texas, 77701, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Buenos Aires, C1202, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Bueno, 1405, Argentina

Location

GSK Investigational Site

Mar del Plata, B7600DHK, Argentina

Location

GSK Investigational Site

Rosario, S2013, Argentina

Location

GSK Investigational Site

Hamilton, Ontario, L8S 1A4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

La Cisterna, 7970000, Chile

Location

GSK Investigational Site

Providencia, 7500000, Chile

Location

GSK Investigational Site

Santiago, 9500000, Chile

Location

GSK Investigational Site

Temuco, 4780000, Chile

Location

GSK Investigational Site

Créteil, 94000, France

Location

GSK Investigational Site

Orléans, 45067, France

Location

GSK Investigational Site

Paris, 75004, France

Location

GSK Investigational Site

Paris, 75015, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Düsseldorf, 40225, Germany

Location

GSK Investigational Site

Frankfurt am Main, 60329, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

München, 80337, Germany

Location

GSK Investigational Site

Foggia, 71100, Italy

Location

GSK Investigational Site

Milan, 20127, Italy

Location

GSK Investigational Site

Milan, 20157, Italy

Location

GSK Investigational Site

Roma, 00149, Italy

Location

GSK Investigational Site

Ponce, 00717-1563, Puerto Rico

Location

GSK Investigational Site

Almería, 04009, Spain

Location

GSK Investigational Site

Granada, 35016, Spain

Location

GSK Investigational Site

La Laguna-Tenerife, 35010, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28031, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Murcia, 30008, Spain

Location

GSK Investigational Site

Seville, 41071, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir; Rilpivirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 26, 2023
• Study Start: July 6, 2023
• Primary Completion: September 16, 2025
• Study Completion: April 22, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

PR (1); CA (2); CL (4); US (15); IT (4); AR (4); DE (4); FR (5); ES (8)