A clinical study of people with HIV-1 who have not taken antiretroviral therapy, one group will start treatment with a combination of doravirine and Islatravir compared to a different group that will start treatment with bictegravir/emtricitabine/tenofovir alafenamide

Phase 1

Recruiting

• 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: CTIS2022-502099-22-01
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 642

Inclusion Criteria

Is an individual =18 years of age of any sex/gender who is HIV-1 positive with plasma HIV-1 RNA =500 copies/mL at screening, Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection, Female is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Exclusion Criteria

Has HIV-2 infection, Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator, Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening, Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive)., Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]), Has a history of malignancy =5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma, Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate

Study & Design

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