Trial Outcomes & Findings for 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) (NCT NCT01717287)
NCT ID: NCT01717287
Last Updated: 2018-08-21
Results Overview
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.
COMPLETED
PHASE2
32 participants
Up to Week 26
2018-08-21
Participant Flow
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
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
28
|
|
Overall Study
COMPLETED
|
4
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
|
Raltegravir Chewable Tablet
n=28 Participants
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
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 to <6 years
|
0 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Customized
6 to <12 years
|
2 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Customized
12 to <18 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Week 26Population: All patients as treated population included all enrolled participants who received at least one dose of study drug
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.
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=28 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Percentage of Participants With at Least One Clinical Adverse Experience
|
0.0 Percentage of participants
|
42.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: All patients as treated population included all enrolled participants who received at least one dose of study drug
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.
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=28 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 26Population: All patients as treated population included all enrolled participants who received at least one dose of study drug
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.
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=28 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Percentage of Participants With at Least One Laboratory Adverse Experience
|
0.0 Percentage of participants
|
3.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: All patients as treated population included all enrolled participants who received at least one dose of study drug
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.
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=28 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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
This outcome is a measure of immunological response to treatment
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=3 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=24 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
|
30.3 cells/mm^3
Interval -178.6 to 239.2
|
296.3 cells/mm^3
Interval 133.6 to 458.9
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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
This outcome is a measure of immunological response to treatment
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=3 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=24 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Change From Baseline in CD4 Cell Percentage
|
4.0 Percentage change
Interval -5.0 to 13.0
|
6.0 Percentage change
Interval 3.8 to 8.1
|
SECONDARY outcome
Timeframe: Week 24Population: 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
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
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=25 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
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
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
88.0 Percentage of participants
Interval 68.8 to 97.5
|
SECONDARY outcome
Timeframe: Week 24Population: 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
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
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=25 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Percentage of Participants Achieving HIV RNA <40 Copies/mL
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
44.0 Percentage of participants
Interval 24.4 to 65.1
|
SECONDARY outcome
Timeframe: Week 24Population: 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
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
Outcome measures
| Measure |
Raltegravir Film-coated Tablet
n=4 Participants
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Raltegravir Chewable Tablet
n=25 Participants
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Percentage of Participants Achieving HIV RNA <200 Copies/mL
|
50.0 Percentage of participants
Interval 6.8 to 93.2
|
76.0 Percentage of participants
Interval 54.9 to 90.6
|
Adverse Events
Raltegravir Film-coated Tablet
Raltegravir Chewable Tablet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Raltegravir Film-coated Tablet
n=4 participants at risk
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
|
Raltegravir Chewable Tablet
n=28 participants at risk
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to Week 26
|
10.7%
3/28 • Number of events 6 • Up to Week 26
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • Up to Week 26
|
7.1%
2/28 • Number of events 2 • Up to Week 26
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Up to Week 26
|
14.3%
4/28 • Number of events 4 • Up to Week 26
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER