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 ID: NCT01717287

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-16
• Study Completion Date: 2013-12-11

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.

Conditions

HIV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raltegravir Film-coated Tablet

Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks

Group Type: EXPERIMENTAL

Raltegravir Film-coated Tablet

Intervention Type: DRUG

Other Anti-Retroviral Therapy

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Raltegravir Chewable Tablet

Intervention Type: DRUG

Other Anti-Retroviral Therapy

Intervention Type: 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

Interventions

Raltegravir Film-coated Tablet

Intervention Type: DRUG

Raltegravir Chewable Tablet

Intervention Type: DRUG

Other Anti-Retroviral Therapy

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

Intervention Type: DRUG

Other Intervention Names

ISENTRESS®; MK-0518; ISENTRESS®; MK-0518

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0518-248

Identifier Type: -

Identifier Source: org_study_id