Phase 2
Completed N=32
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)
Source: ClinicalTrials.gov NCT01717287 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Percentage of Participants With at Least One Clinical Adverse Experience — 0.0; 42.9 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Clinical Adverse Experience |
0.0; 42.9 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants With at Least One Laboratory Adverse Experience |
0.0; 3.6 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count |
30.3; 296.3 | — |
| SECONDARY Change From Baseline in CD4 Cell Percentage |
4.0; 6.0 | — |
| 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 |
75.0; 88.0 | — |
| SECONDARY Percentage of Participants Achieving HIV RNA <40 Copies/mL |
50.0; 44.0 | — |
| SECONDARY Percentage of Participants Achieving HIV RNA <200 Copies/mL |
50.0; 76.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01717287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.