A clinical study of people with HIV-1 who switch their treatment to a combination of doravirine and islatravir??

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: CTIS2022-502079-49-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

Participants =18 years of age, Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL, Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for =3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen, Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, 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 a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening, Has active hepatitis B virus (HBV) infection, Has chronic hepatitis C virus (HCV) infection with laboratory values consistent with cirrhosis, 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, Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers, Has a documented or known virologic resistance to DOR, Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir), Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing DOR/ISL study

Study & Design

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