Safety and Efficacy of MK-1439A in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030) (DRIVE BEYOND)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
First received: December 10, 2015
Last updated: July 5, 2018
Last Verified: July 2018
History of Changes
The primary objectives of this study are to evaluate the antiretroviral activity and to evaluate the safety and tolerability of open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg in treatment-naive HIV-1 infected participants with selected NNRTI transmitted resistance mutations.
Drug : MK-1439A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations|
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures
- Percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
- Number of participants with one or more adverse event (AE) [ Time Frame: Up to Week 96 ]
- Number of participants who discontinued treatment due to an AE [ Time Frame: Up to Week 96 ]
|Study Start Date:||January 14, 2016|
|Estimated Study Completion Date:||October 29, 2020|
|Estimated Primary Completion Date:||December 13, 2018 (Final data collection date for primary outcome measure)|
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance will be treated with open-label MK-1439A consisting of a single FDC tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg, to be administered orally, once daily for up to 96 weeks. For some participants who continue into the study extension, study treatment will continue for an additional 96 weeks, approximately, through a total of approximately 192 weeks of treatment.
A single FDC tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg will be administered orally, once daily for up to 96 weeks. For some participants who continue into the study extension, study treatment will continue for an additional 96 weeks, approximately, through a total of approximately 192 weeks of treatment.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 (MK-1439, 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
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02629822
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT02629822 History of Changes|
|Other Study ID Numbers:||1439A-030|
|Study First Received:||December 10, 2015|
|Last Updated:||July 5, 2018|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Reverse Transcriptase Inhibitors
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.