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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02629822
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Results First Posted : December 26, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1 Infection Drug: MK-1439A Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Actual Study Start Date : January 14, 2016
Actual Primary Completion Date : November 28, 2018
Estimated Study Completion Date : October 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629822


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme Corp.:
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02629822    
Other Study ID Numbers: 1439A-030
2015-003616-20 ( EudraCT Number )
MK-1439A-030 ( Other Identifier: Merck Protocol Number )
First Posted: December 14, 2015    Key Record Dates
Results First Posted: December 26, 2019
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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