Clinical trial NCT01717287: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2012-10-30
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With at Least One Clinical Adverse Experience
timeFrame: Up to Week 26
measure: Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
timeFrame: Up to Week 24
measure: Percentage of Participants With at Least One Laboratory Adverse Experience
timeFrame: Up to Week 26
measure: Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
timeFrame: Up to Week 24
Secondary outcomes:
measure: Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
timeFrame: Baseline and Week 24
measure: Change From Baseline in CD4 Cell Percentage
timeFrame: Baseline and Week 24
measure: 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
timeFrame: Week 24
measure: Percentage of Participants Achieving HIV RNA <40 Copies/mL
timeFrame: Week 24
measure: Percentage of Participants Achieving HIV RNA <200 Copies/mL
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: