HIV InfectionPhase 2NCT01717287
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)
A Phase 2 study testing Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet and Other Anti-Retroviral Therapy in people with HIV Infection, run by Merck Sharp & Dohme LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet and Other Anti-Retroviral Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2012to 11 Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
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
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.
- Conditions
- HIV Infection
- Being tested
- Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet, Other Anti-Retroviral Therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir Film-coated TabletDrug
Also called ISENTRESS®, MK-0518
Raltegravir Chewable TabletDrug
Also called ISENTRESS®, MK-0518
Other Anti-Retroviral TherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir Film-coated Tablet | Experimental | Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks Receives: Drug: Raltegravir Film-coated Tablet; Drug: Other Anti-Retroviral Therapy |
| Raltegravir Chewable Tablet | Experimental | Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks Receives: Drug: Raltegravir Chewable Tablet; Drug: Other Anti-Retroviral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Clinical Adverse Experience
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.
Measured: Up to Week 26
Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
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.
Measured: Up to Week 24
Percentage of Participants With at Least One Laboratory Adverse Experience
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.
Measured: Up to Week 26
Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
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.
Measured: Up to Week 24
Secondary outcomes (5)
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
This outcome is a measure of immunological response to treatment
Measured: Baseline and Week 24
Change From Baseline in CD4 Cell Percentage
This outcome is a measure of immunological response to treatment
Measured: Baseline and Week 24
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
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
Measured: Week 24
Percentage of Participants Achieving HIV RNA <40 Copies/mL
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
Measured: Week 24
Percentage of Participants Achieving HIV RNA <200 Copies/mL
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
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study start16 Nov 2012
- Primary completion11 Dec 2013
- Study completion11 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717287
- Sponsor's protocol ID
- 0518-248
- Status last verified
- Jul 2018
- First submitted
- 26 Oct 2012
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01717287
- Acronym / sponsor ID
- 0518-248
- Conditions
- HIV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 16 Nov 2012 (actual)
- Primary completion
- 11 Dec 2013 (actual)
- Study completion
- 11 Dec 2013 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 29 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir Film-coated Tablet | Experimental | Drug: Raltegravir Film-coated Tablet, Drug: Other Anti-Retroviral TherapyRaltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks |
| Raltegravir Chewable Tablet | Experimental | Drug: Raltegravir Chewable Tablet, Drug: Other Anti-Retroviral TherapyRaltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raltegravir Film-coated TabletAlso: ISENTRESS®, MK-0518 | Drug | Raltegravir Film-coated Tablet |
| Raltegravir Chewable TabletAlso: ISENTRESS®, MK-0518 | Drug | Raltegravir Chewable Tablet |
| Other Anti-Retroviral TherapyAt 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 | Drug | Raltegravir Chewable Tablet, Raltegravir Film-coated Tablet |
Primary outcome
Percentage of Participants With at Least One Clinical Adverse Experience
Time frame: Up to Week 26
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
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
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
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.
5 secondary outcomes
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
Time frame: Baseline and Week 24
Change From Baseline in CD4 Cell Percentage
Time frame: Baseline and Week 24
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
Percentage of Participants Achieving HIV RNA <40 Copies/mL
Time frame: Week 24
Percentage of Participants Achieving HIV RNA <200 Copies/mL
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet and Other Anti-Retroviral Therapy in people with HIV Infection, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least One Clinical Adverse Experience (time frame: Up to Week 26). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.