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 (MSD)

Status and phase: Completed; Phase 2

Conditions: HIV Infection

Treatments: Drug: Raltegravir Film-coated Tablet; Drug: Other Anti-Retroviral Therapy; Drug: Raltegravir Chewable Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01717287

0518-248

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Raltegravir Film-coated Tablet

Experimental group

Description:

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

Treatment:

Drug: Other Anti-Retroviral Therapy

Drug: Raltegravir Film-coated Tablet

Raltegravir Chewable Tablet

Experimental group

Description:

Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks

Treatment:

Drug: Other Anti-Retroviral Therapy

Drug: Raltegravir Chewable Tablet