Clinical Trials

MainTitle

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)

This study is ongoing, but not recruiting participants.
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT02629822

First received: December 10, 2015
Last updated: January 24, 2020
Last Verified: January 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-1 Infection

Drug : MK-1439A
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
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 of Plasma at Week 48 [ Time Frame: Week 48 ]
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit.
  • Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48 [ Time Frame: Up to Week 48 ]
    The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
  • Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48. [ Time Frame: Up to Week 48 ]
    The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
  • Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96 [ Time Frame: Up to Week 96 ]
    The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
  • Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96 [ Time Frame: Up to Week 96 ]
    The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Secondary Outcome Measures:
  • Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit.
  • Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48 [ Time Frame: Week 48 ]
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
  • Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
  • Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ]
    The change from baseline in CD4 cell count at Week 48 was calculated.
  • Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ]
    The change from baseline in CD4 cell count at Week 96 was calculated.
  • Time to Loss of Virologic Response [ Time Frame: Up to Week 96 ]
    The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement.

Enrollment: 10
Study Start Date: January 14, 2016
Estimated Study Completion Date: October 29, 2020
Estimated Primary Completion Date: November 28, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: DOR/3TC/TDF
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Drug: MK-1439A

A single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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 (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
any time during the study

contacts and locations

Contacts and Locations

Choosing 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 Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT02629822   History of Changes  
Other Study ID Numbers: 1439A-030  
  2015-003616-20  
  MK-1439A-030  
Study First Received: December 10, 2015  
Last Updated: January 24, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.