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)
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Raltegravir Film-coated Tablet; Raltegravir Chewable Tablet; Other Anti-Retroviral Therapy
Intervention description: 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 MeSH terms: Raltegravir Potassium; Anti-Retroviral Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

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