Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030) (DRIVE BEYOND)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HIV-1 Infection

Treatments: Drug: Doravirine/lamivudine/tenofovir disoproxil fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02629822

MK-1439A-030 (Other Identifier)

2015-003616-20 (EudraCT Number)

1439A-030

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations.

Full description

This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment.
• Is naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
• Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A.
• Is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
• Is highly unlikely to become pregnant or to impregnate a partner

Exclusion criteria

• Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
• Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
• Has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir)
• Has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
• Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
• Requires or anticipates requiring any of the prohibited medications
• Has significant hypersensitivity or other contraindication to any of the components of the study drug
• Has a current (active) diagnosis of acute hepatitis due to any cause
• Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9
• Is pregnant, breastfeeding, or expecting to conceive
• Is female and expecting to donate eggs, or is male and is expecting to donate sperm at any time during the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

DOR/3TC/TDF

Experimental group

Description:

Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.

Treatment:

Drug: Doravirine/lamivudine/tenofovir disoproxil fumarate