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Completed

NCT Number: NCT01717287

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)

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raltegravir Film-coated Tablet

Drug

Other names: ISENTRESS®, MK-0518

Raltegravir chewable tablet

Drug

Other names: ISENTRESS®, MK-0518

Other Anti-Retroviral Therapy

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

Primary outcomes

  1. Percentage of Participants With at Least One Clinical Adverse Experience

    Time frame: 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.

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

    Time frame: 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.

  3. Percentage of Participants With at Least One Laboratory Adverse Experience

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: Baseline and Week 24

    This outcome is a measure of immunological response to treatment

  2. Change From Baseline in CD4 Cell Percentage

    Time frame: Baseline and Week 24

    This outcome is a measure of immunological response to treatment

  3. 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

    Time frame: 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

  4. Percentage of Participants Achieving HIV RNA <40 Copies/mL

    Time frame: 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

  5. Percentage of Participants Achieving HIV RNA <200 Copies/mL

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Covance

Registry information

Official study title

A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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