A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)

This study has been completed.
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717287
First received: October 26, 2012
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: June 30, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: Raltegravir Film-coated Tablet
Drug: Raltegravir Chewable Tablet
Drug: Other Anti-Retroviral Therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Film-coated tablets were administered to participants >=12 years old and to those 6 to <12 years old who weighed >=25 kg and could swallow pills. A weight-based dose of chewable tablets was administered to participants 6 to <12 years old who could not swallow pills or preferred the chewable formulation, and to participants 2 to <6 years old

Reporting Groups
  Description
Raltegravir Film-coated Tablet Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
Raltegravir Chewable Tablet Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks

Participant Flow:   Overall Study
    Raltegravir Film-coated Tablet     Raltegravir Chewable Tablet  
STARTED     4     28  
COMPLETED     4     25  
NOT COMPLETED     0     3  
Lost to Follow-up                 0                 2  
Protocol Violation                 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.
No text entered.

Reporting Groups
  Description
Raltegravir Film-coated Tablet Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
Raltegravir Chewable Tablet Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Raltegravir Film-coated Tablet     Raltegravir Chewable Tablet     Total  
Number of Participants  
[units: participants]
  4     28     32  
Age, Customized  
[units: Participants]
     
2 to <6 years     0     11     11  
6 to <12 years     2     17     19  
12 to <18 years     2     0     2  
Gender  
[units: Participants]
     
Female     1     16     17  
Male     3     12     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With at Least One Clinical Adverse Experience   [ Time Frame: Up to Week 26 ]

2.  Primary:   Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience   [ Time Frame: Up to Week 24 ]

3.  Primary:   Percentage of Participants With at Least One Laboratory Adverse Experience   [ Time Frame: Up to Week 26 ]

4.  Primary:   Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience   [ Time Frame: Up to Week 24 ]

5.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Change From Baseline in CD4 Cell Percentage   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL   [ Time Frame: Week 24 ]

8.  Secondary:   Percentage of Participants Achieving HIV RNA <40 Copies/mL   [ Time Frame: Week 24 ]

9.  Secondary:   Percentage of Participants Achieving HIV RNA <200 Copies/mL   [ Time Frame: Week 24 ]


  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
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  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01717287     History of Changes
Other Study ID Numbers: 0518-248
Study First Received: October 26, 2012
Results First Received: June 30, 2014
Last Updated: August 4, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee