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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717287
First received: October 26, 2012
Last updated: December 30, 2013
Last verified: December 2013

October 26, 2012
December 30, 2013
November 2012
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01717287 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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 HIV-1
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) 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.

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
    Raltegravir 400 mg film-coated tablet orally b.i.d.
    Other Names:
    • ISENTRESS®
    • MK-0518
  • 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
  • Experimental: Raltegravir Film-coated Tablet
    Raltegravir 400 mg administered orally twice daily (b.i.d.)
    Intervention: Drug: Raltegravir Film-coated Tablet
  • Experimental: Raltegravir Chewable Tablet
    Raltegravir administered b.i.d. at a weight-based dose not to exceed 300 mg b.i.d.
    Intervention: Drug: Raltegravir Chewable Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
December 2013

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