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) - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: Raltegravir Film-coated Tablet Drug: Raltegravir Chewable Tablet Drug: Other Anti-Retroviral Therapy	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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


Enrollment:	32
Study Start Date:	November 2012
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: Raltegravir Film-coated 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 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	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

Eligibility


Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717287

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Covance

Investigators


Study Director:	Medical Director	Merck Sharp & Dohme Corp.

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01717287 History of Changes
Other Study ID Numbers:	0518-248
Study First Received:	October 26, 2012
Results First Received:	June 30, 2014
Last Updated:	February 2, 2015
Health Authority:	Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee

ClinicalTrials.gov processed this record on March 01, 2015