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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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 groups in NCT01717287
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.

16 Nov 201211 Dec 2013

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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.

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

Results posted to the registry on 29 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Raltegravir Film-coated Tablet	4	4
Raltegravir Chewable Tablet	28	25

Primary outcome: Percentage of Participants With at Least One Clinical Adverse Experience

Time frame: Up to Week 26. Number. Unit: Percentage of participants

Measure	Raltegravir Film-coated Tablet n = 4	Raltegravir Chewable Tablet n = 28
Value	0.0	42.9

Population analysed: All patients as treated population included all enrolled participants who received at least one dose of study drug

Primary outcome: Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience

Time frame: Up to Week 24. Number. Unit: Percentage of participants

Measure	Raltegravir Film-coated Tablet n = 4	Raltegravir Chewable Tablet n = 28
Value	0.0	0.0

Population analysed: All patients as treated population included all enrolled participants who received at least one dose of study drug

Primary outcome: Percentage of Participants With at Least One Laboratory Adverse Experience

Time frame: Up to Week 26. Number. Unit: Percentage of participants

Measure	Raltegravir Film-coated Tablet n = 4	Raltegravir Chewable Tablet n = 28
Value	0.0	3.6

Population analysed: All patients as treated population included all enrolled participants who received at least one dose of study drug

Primary outcome: Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience

Time frame: Up to Week 24. Number. Unit: Percentage of participants

Measure	Raltegravir Film-coated Tablet n = 4	Raltegravir Chewable Tablet n = 28
Value	0.0	0.0

Population analysed: All patients as treated population included all enrolled participants who received at least one dose of study drug

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 26. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir Film-coated Tablet	0 of 4 (0%)	0 of 4 (0%)	Not reported
Raltegravir Chewable Tablet	0 of 28 (0%)	8 of 28 (28.6%)	Not reported

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?

On the ClinicalTrials.gov record for NCT01717287.

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; AzTrials last refreshed its copy on 8 Nov 2026.