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)

HIV Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717287
• Other study ID #: 0518-248
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2012
• Est. completion date: December 11, 2013

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 11, 2013
• Est. primary completion date: December 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Raltegravir Film-coated Tablet

• Raltegravir Chewable Tablet

• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Covance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count	This outcome is a measure of immunological response to treatment	Baseline and Week 24
Secondary	Change From Baseline in CD4 Cell Percentage	This outcome is a measure of immunological response to treatment	Baseline and Week 24
Secondary	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	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	Week 24
Secondary	Percentage of Participants Achieving HIV RNA <40 Copies/mL	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	Week 24
Secondary	Percentage of Participants Achieving HIV RNA <200 Copies/mL	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	Week 24