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)

NCT01717287 | Completed Phase 2 Results

• 1 other identifier: 0518-248
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With at Least One Clinical Adverse Experience

  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.

  Up to Week 26

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

  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.

  Up to Week 24

• Percentage of Participants With at Least One Laboratory Adverse Experience

  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.

  Up to Week 26

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

  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.

  Up to Week 24

Secondary Outcomes (5)

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

  Baseline and Week 24

• Change From Baseline in CD4 Cell Percentage

  Baseline and Week 24

• 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

  Week 24

• Percentage of Participants Achieving HIV RNA <40 Copies/mL

  Week 24

• Percentage of Participants Achieving HIV RNA <200 Copies/mL

  Week 24

Study Arms (2)

Raltegravir Film-coated Tablet

EXPERIMENTAL

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

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

Raltegravir Chewable Tablet

EXPERIMENTAL

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

Drug: Raltegravir Chewable Tablet; Drug: Other Anti-Retroviral Therapy

Interventions

Raltegravir Film-coated Tablet DRUG

Also known as: ISENTRESS®, MK-0518

Raltegravir Film-coated Tablet

Raltegravir Chewable Tablet DRUG

Also known as: ISENTRESS®, MK-0518

Raltegravir Chewable Tablet

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

Raltegravir Chewable Tablet; Raltegravir Film-coated Tablet

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Covance: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: November 16, 2012
• Primary Completion: December 11, 2013
• Study Completion: December 11, 2013
• Last Updated: August 21, 2018
• Results First Posted: July 29, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share