Text Size

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 HIV-1

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01717287
First received: October 26, 2012
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-inexperienced 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
 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
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir Film-coated Tablet
Raltegravir 400 mg administered orally twice daily (b.i.d.)
 Drug: Raltegravir Film-coated Tablet
Raltegravir 400 mg film-coated tablet orally b.i.d.
Other Names:
  • ISENTRESS®
  • MK-0518
Experimental: Raltegravir Chewable Tablet
Raltegravir administered b.i.d. at a weight-based dose not to exceed 300 mg b.i.d.
 Drug: Raltegravir Chewable Tablet
Raltegravir chewable tablet orally b.i.d. at a dose not to exceed 300 mg b.i.d.
Other Names:
  • ISENTRESS®
  • MK-0518

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

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva     7 0959410000        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01717287     History of Changes
Other Study ID Numbers: 0518-248
Study First Received: October 26, 2012
Last Updated: March 13, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013