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)
- Conditions
- HIV Infection
- Interventions
- Drug: Other Anti-Retroviral Therapy
- Registration Number
- NCT01717287
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- HIV positive
- Weight of at least 7 kg
- HIV RNA ≥1000 copies/mL within 45 days before study treatment
- Participants of reproductive potential and sexually active agree to remain
abstinent or use (or have their partner use) an acceptable method of birth control throughout the study.
- Females pregnant or breast-feeding, or expecting to conceive or donate eggs
during the study; males planning to impregnate or provide sperm donation
during the study
- Use of any non-antiretroviral (ART) investigational agents within one month before study treatment
- Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and/or C
- Prior or current use of raltegravir
- Use of another experimental HIV-integrase inhibitor
- History or current evidence of any condition, therapy, laboratory
abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study
- Requires or is anticipated to require any prohibited medications
- Use of immunosuppressive therapy within 30 days before beginning
raltegravir study treatment; short courses of corticosteroids are permitted.
- History of malignancy
- Current treatment for active tuberculosis infection
- Use of recreational or illicit drugs or a recent history (within the
last year) of drug or alcohol abuse or dependence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Raltegravir Film-coated Tablet 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 Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks Raltegravir Film-coated Tablet Other Anti-Retroviral Therapy Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks Raltegravir Chewable Tablet Other Anti-Retroviral Therapy Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Clinical Adverse Experience Up to Week 26 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.
Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience Up to Week 24 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.
Percentage of Participants With at Least One Laboratory Adverse Experience Up to Week 26 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.
Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience Up to Week 24 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.
- Secondary Outcome Measures
Name Time Method 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 Week 24 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
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count Baseline and Week 24 This outcome is a measure of immunological response to treatment
Change From Baseline in CD4 Cell Percentage Baseline and Week 24 This outcome is a measure of immunological response to treatment
Percentage of Participants Achieving HIV RNA <40 Copies/mL Week 24 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
Percentage of Participants Achieving HIV RNA <200 Copies/mL Week 24 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