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 HIV-1 in adults who have not previously taken antiretroviral therapy.

Phase 1

• Conditions: HIV-1 infection; MedDRA version: 20.1Level: LLTClassification code: 10068341Term: HIV-1 infection Class: 10021881; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2023-503893-19-00
• Lead Sponsor: Viiv Healthcare UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• Age =18 years (or older, if required by local regulations) at the time of obtaining informed consent., • Male or female. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrolment) and not lactating., • Plasma HIV-1 RNA =1,000 c/mL at Screening., • Antiretroviral-naïve (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. Eligible participants must sign a written ICF before any protocol-specified assessments are conducted. Enrolment of participants 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., • 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 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., • Signs and symptoms which, in the opinion of the Investigator, are suggestive of active SARS-CoV-2 infection within 14 days prior to enrolment., • Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment) are excluded. Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. Participants who completed treatment at least 7 days prior to Screening are eligible., • 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 first dose of study treatment., • 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., • Ongoing or clinically relevant pancreatitis., • 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., • 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., • 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., • 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)., • History of liver cirrhosis with or without hepatitis viral co-infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified