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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1).
As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use
of raltegravir in the pediatric HIV-infected population in Russia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir Film-coated Tablet | Experimental | Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks |
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| Raltegravir Chewable Tablet | Experimental | Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir Film-coated Tablet | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Clinical Adverse Experience | 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. | Up to Week 26 |
| Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience | 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. | Up to Week 24 |
| Percentage of Participants With at Least One Laboratory Adverse Experience | 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. | Up to Week 26 |
| Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience | 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. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count | This outcome is a measure of immunological response to treatment | Baseline and Week 24 |
| Change From Baseline in CD4 Cell Percentage |
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Inclusion Criteria:
abstinent or use (or have their partner use) an acceptable method of birth control throughout the study.
Exclusion Criteria:
during the study; males planning to impregnate or provide sperm donation
during the study
abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study
raltegravir study treatment; short courses of corticosteroids are permitted.
last year) of drug or alcohol abuse or dependence
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir Film-coated Tablet | Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks. |
| FG001 | Raltegravir Chewable Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Raltegravir Chewable Tablet |
| Drug |
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| Other Anti-Retroviral Therapy | Drug | At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing |
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This outcome is a measure of immunological response to treatment
| Baseline and Week 24 |
| 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 | 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 | Week 24 |
| Percentage of Participants Achieving HIV RNA <40 Copies/mL | 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 | Week 24 |
| Percentage of Participants Achieving HIV RNA <200 Copies/mL | 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 | Week 24 |
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir Film-coated Tablet | Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Clinical Adverse Experience | 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. | All patients as treated population included all enrolled participants who received at least one dose of study drug | Posted | Number | Percentage of participants | Up to Week 26 |
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| Primary | Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience | 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. | All patients as treated population included all enrolled participants who received at least one dose of study drug | Posted | Number | Percentage of participants | Up to Week 24 |
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| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count | This outcome is a measure of immunological response to treatment | 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 | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline and Week 24 |
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| Secondary | Change From Baseline in CD4 Cell Percentage | This outcome is a measure of immunological response to treatment | 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 | Posted | Mean | 95% Confidence Interval | Percentage change | Baseline and Week 24 |
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| Primary | Percentage of Participants With at Least One Laboratory Adverse Experience | 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. | All patients as treated population included all enrolled participants who received at least one dose of study drug | Posted | Number | Percentage of participants | Up to Week 26 |
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience | 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. | All patients as treated population included all enrolled participants who received at least one dose of study drug | Posted | Number | Percentage of participants | Up to Week 24 |
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| 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 | 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 | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving HIV RNA <40 Copies/mL | 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 | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving HIV RNA <200 Copies/mL | 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 | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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Up to Week 26
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raltegravir Film-coated Tablet | Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks. | 0 | 4 | 0 | 4 | ||
| EG001 | 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 | 0 | 28 | 8 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 |
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| Otitis media | Infections and infestations | MedDRA 16.1 |
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| Respiratory tract infection | Infections and infestations | MedDRA 16.1 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
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| 12 to <18 years |
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| Male |
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