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 study has been completed.
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717287
First received: October 26, 2012
Last updated: August 4, 2014
Last verified: August 2014

October 26, 2012
August 4, 2014
November 2012
December 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants With at Least One Clinical Adverse Experience [ Time Frame: Up to Week 26 ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants With at Least One Laboratory Adverse Experience [ Time Frame: Up to Week 26 ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants With at Least One Adverse Experience (AE) [ Time Frame: Up to 26 Weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants who Discontinued Study Treatment due to AEs [ Time Frame: Up to 24 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01717287 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This outcome is a measure of immunological response to treatment
  • Change From Baseline in CD4 Cell Percentage [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This outcome is a measure of immunological response to treatment
  • 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 ] [ Designated as safety issue: No ]
    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
  • Percentage of Participants Achieving HIV RNA <40 Copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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
  • Percentage of Participants Achieving HIV RNA <200 Copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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
  • Percentage of Participants Achieving ≥1 Log^10 Reduction from Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or HIV RNA <200 copies/mL [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HIV RNA <40 copies/mL [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HIV RNA <200 copies/mL [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Cluster of Differentiation 4 (CD4) Cell Count (cells/mm^3) [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in CD4 Percent [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: Raltegravir Film-coated Tablet
    Other Names:
    • ISENTRESS®
    • MK-0518
  • Drug: Raltegravir Chewable Tablet
    Other Names:
    • ISENTRESS®
    • MK-0518
  • 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
  • Experimental: Raltegravir Film-coated Tablet
    Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
    Interventions:
    • Drug: Raltegravir Film-coated Tablet
    • Drug: Other Anti-Retroviral Therapy
  • Experimental: 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
    Interventions:
    • Drug: Raltegravir Chewable Tablet
    • Drug: Other Anti-Retroviral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01717287
0518-248
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Covance
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP