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Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01353898
First received: May 12, 2011
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: January 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: MK-1972
Drug: Placebo to MK-1972

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Two treatment groups planned for Part II (800 mg MK-1972 twice daily, and Placebo twice daily) were not enrolled, and are therefore not included in these Results.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MK-1972 50 mg Once Daily (Part I) Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 200 mg Once Daily (Part I) Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 800 mg Once Daily (Part I) Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 25 mg Twice Daily (Part I) Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 100 mg Twice Daily (Part I) Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Placebo Twice Daily (Part I) Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)

Participant Flow:   Overall Study
    MK-1972 50 mg Once Daily (Part I)     MK-1972 200 mg Once Daily (Part I)     MK-1972 800 mg Once Daily (Part I)     MK-1972 25 mg Twice Daily (Part I)     MK-1972 100 mg Twice Daily (Part I)     Placebo Twice Daily (Part I)  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     1  
NOT COMPLETED     0     0     0     0     0     1  
Study site terminated                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants

Reporting Groups
  Description
MK-1972 50 mg Once Daily (Part I) Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 200 mg Once Daily (Part I) Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 800 mg Once Daily (Part I) Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
MK-1972 25 mg Twice Daily (Part I) Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
MK-1972 100 mg Twice Daily (Part I) Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
Placebo Twice Daily (Part I) Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
Total Total of all reporting groups

Baseline Measures
    MK-1972 50 mg Once Daily (Part I)     MK-1972 200 mg Once Daily (Part I)     MK-1972 800 mg Once Daily (Part I)     MK-1972 25 mg Twice Daily (Part I)     MK-1972 100 mg Twice Daily (Part I)     Placebo Twice Daily (Part I)     Total  
Number of Participants  
[units: participants]
  2     2     2     2     2     2     12  
Age  
[units: Years]
Mean (Standard Deviation)
  31.5  (14.8)     24.0  (2.8)     32.5  (0.7)     47.5  (10.6)     37.0  (1.4)     37.0  (17.0)     34.9  (10.6)  
Gender  
[units: Participants]
             
Female     0     0     0     0     0     0     0  
Male     2     2     2     2     2     2     12  



  Outcome Measures
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1.  Primary:   Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)   [ Time Frame: From consent to 14 days after the last dose (up to Day 24) ]

2.  Primary:   Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo   [ Time Frame: Baseline and Day 10 (24 hours post-dose) ]

3.  Secondary:   The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection   [ Time Frame: Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01353898     History of Changes
Other Study ID Numbers: 1972-003
2011-000071-14 ( EudraCT Number )
Study First Received: May 12, 2011
Results First Received: January 6, 2016
Last Updated: January 6, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices