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)

Merck Sharp & Dohme LLC32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: Up to Week 26

Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience

Time frame: 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.

Time frame: Up to Week 26

Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience

Time frame: Up to Week 24

Secondary Outcomes

Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count

This outcome is a measure of immunological response to treatment

Time frame: Baseline and Week 24

Change From Baseline in CD4 Cell Percentage

This outcome is a measure of immunological response to treatment

Time frame: 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

Time frame: Week 24

Percentage of Participants Achieving HIV RNA <40 Copies/mL

Time frame: Week 24

Percentage of Participants Achieving HIV RNA <200 Copies/mL

Time frame: Week 24