A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily… (NCT05917509) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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
United States171 participantsStarted 2023-07-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
✕. Participants with any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count \<200 cells/cubic millimetre (mm\^3) (neither is exclusionary).
✕. 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.
What they're measuring
1
[DTG/3TC]: Time to Virologic Suppression (HIV-1 Ribonucleic Acid [RNA] <50 Copies per Millilitre [c/mL]) From Baseline (Day 1)
Timeframe: Baseline (Day 1) up to Month 12
2
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 11
✕. 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 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 Medical Monitor for inclusion of the participant prior to enrolment.
✕. 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).