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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)

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ClinicalTrials.gov Identifier: NCT01717287
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : July 29, 2014
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Drug: Raltegravir Film-coated Tablet
Drug: Raltegravir Chewable Tablet
Drug: Other Anti-Retroviral Therapy
Enrollment 32
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks. Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Period Title: Overall Study
Started 4 28
Completed 4 25
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             2
Protocol Violation             0             1
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet Total
Hide Arm/Group Description Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks. 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 of all reporting groups
Overall Number of Baseline Participants 4 28 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 28 participants 32 participants
2 to <6 years 0 11 11
6 to <12 years 2 17 19
12 to <18 years 2 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 28 participants 32 participants
Female
1
  25.0%
16
  57.1%
17
  53.1%
Male
3
  75.0%
12
  42.9%
15
  46.9%
1.Primary Outcome
Title Percentage of Participants With at Least One Clinical Adverse Experience
Hide Description A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Time Frame Up to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients as treated population included all enrolled participants who received at least one dose of study drug
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 28
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 42.9
2.Primary Outcome
Title Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
Hide Description A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients as treated population included all enrolled participants who received at least one dose of study drug
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 28
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0
3.Primary Outcome
Title Percentage of Participants With at Least One Laboratory Adverse Experience
Hide Description A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Time Frame Up to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients as treated population included all enrolled participants who received at least one dose of study drug
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 28
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 3.6
4.Primary Outcome
Title Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
Hide Description A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients as treated population included all enrolled participants who received at least one dose of study drug
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 28
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0
5.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
Hide Description This outcome is a measure of immunological response to treatment
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 3 24
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
30.3
(-178.6 to 239.2)
296.3
(133.6 to 458.9)
6.Secondary Outcome
Title Change From Baseline in CD4 Cell Percentage
Hide Description This outcome is a measure of immunological response to treatment
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 3 24
Mean (95% Confidence Interval)
Unit of Measure: Percentage change
4.0
(-5.0 to 13.0)
6.0
(3.8 to 8.1)
7.Secondary Outcome
Title 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
Hide Description This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75.0
(19.4 to 99.4)
88.0
(68.8 to 97.5)
8.Secondary Outcome
Title Percentage of Participants Achieving HIV RNA <40 Copies/mL
Hide Description This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.0
(6.8 to 93.2)
44.0
(24.4 to 65.1)
9.Secondary Outcome
Title Percentage of Participants Achieving HIV RNA <200 Copies/mL
Hide Description This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description:
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Overall Number of Participants Analyzed 4 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.0
(6.8 to 93.2)
76.0
(54.9 to 90.6)
Time Frame Up to Week 26
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Hide Arm/Group Description Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks. Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
All-Cause Mortality
Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir Film-coated Tablet Raltegravir Chewable Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      8/28 (28.57%)    
Gastrointestinal disorders     
Vomiting  0/4 (0.00%)  0 3/28 (10.71%)  6
Infections and infestations     
Otitis media  0/4 (0.00%)  0 2/28 (7.14%)  2
Respiratory tract infection  0/4 (0.00%)  0 4/28 (14.29%)  4
1
Term from vocabulary, MedDRA 16.1
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 sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01717287     History of Changes
Other Study ID Numbers: 0518-248
First Submitted: October 26, 2012
First Posted: October 30, 2012
Results First Submitted: June 30, 2014
Results First Posted: July 29, 2014
Last Update Posted: August 21, 2018