Human Immunodeficiency VirusPhase 3NCT00764946

A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

A Phase 3 study testing Comparator: raltegravir in people with Human Immunodeficiency Virus, 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

Search all trials

Trial summary

A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Comparator: raltegravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: No sites listed yet
Study dates: Oct 2008to Feb 2011
Phase: Phase 3
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient is HIV positive
Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Who cannot join

If female, pregnant or breastfeeding
Patient has used an investigational agent in the last 30 days
Patient has acute hepatitis
Patient has received MK0518 (raltegravir) before
Patient has used another experimental HIV-integrase inhibitor

About this study

Official title: A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients

Conditions: Human Immunodeficiency Virus
Being tested: Comparator: raltegravir
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: raltegravirDrug
Also called ISENTRESS
400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Study groups in NCT00764946
Study group	Role	What they receive
1	Experimental	raltegravir Receives: Drug: Comparator: raltegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.
Measured: Week 48
Number of Participants With One or More Adverse Events
Numbers of participants with one or more adverse events were summarized by race.
Measured: Week 48
Number of Participants Who Discontinued Due to an Adverse Event
Numbers of participants who discontinued due to an adverse event were summarized by race.
Measured: Week 48

Secondary outcomes (4)

Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.
Measured: Week 48
Mean Change From Baseline to Week 48 in HIV RNA
Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.
Measured: Baseline and Week 48
Mean Change From Baseline to Week 48 in CD4 Cell Count
Mean changes from baseline in CD4 cell counts were summarized by race at each time point.
Measured: Baseline and Week 48
Number of Participants Without Loss of Virologic Response
For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).
Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Feb 2011

First posted2 Oct 2008 (estimated)
Study startOct 2008
Primary completionFeb 2011
Study completionFeb 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00764946
Sponsor's protocol ID: 0518-055
Other IDs: 2008_555
Status last verified: Feb 2017
First submitted: 1 Oct 2008
Last updated: 21 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Squires KE, Bekker LG, Eron JJ, Cheng B, Rockstroh JK, Marquez F, Kumar P, Thompson M, Campo RE, Mounzer K, Strohmaier KM, Lu C, Rodgers A, Jackson BE, Wenning LA, Robertson M, Nguyen BY, Sklar P; REALMRK Investigators. Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study. AIDS Res Hum Retroviruses. 2013 Jun;29(6):859-70. doi: 10.1089/AID.2012.0292. Epub 2013 Feb 26.
PubMed 23351187

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

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients
ClinicalTrials.gov ID: NCT00764946
Acronym / sponsor ID: 0518-055
Conditions: Human Immunodeficiency Virus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 12 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Comparator: raltegravirraltegravir

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patient is HIV positive
Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Key exclusion criteria (5 listed)

If female, pregnant or breastfeeding
Patient has used an investigational agent in the last 30 days
Patient has acute hepatitis
Patient has received MK0518 (raltegravir) before
Patient has used another experimental HIV-integrase inhibitor

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
Comparator: raltegravirAlso: ISENTRESS400 mg tablets taken twice daily. Total treatment period is 48 weeks.	Drug	1

Primary outcome

Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Time frame: Week 48
Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.
Number of Participants With One or More Adverse Events
Time frame: Week 48
Numbers of participants with one or more adverse events were summarized by race.
Number of Participants Who Discontinued Due to an Adverse Event
Time frame: Week 48
Numbers of participants who discontinued due to an adverse event were summarized by race.

4 secondary outcomes

Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Time frame: Week 48
Mean Change From Baseline to Week 48 in HIV RNA
Time frame: Baseline and Week 48
Mean Change From Baseline to Week 48 in CD4 Cell Count
Time frame: Baseline and Week 48
Number of Participants Without Loss of Virologic Response
Time frame: Week 48

Results and safety

Results posted to the registry on 12 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Failing Current Therapy	98	85
Participants Intolerant to Current Therapy	89	72
Participants Treatment Naive	22	18

Primary outcome: Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

Time frame: Week 48. Number. Unit: Participants

Measure	Treatment Experienced - Failing Current Therapy n = 94	Treatment Experienced - Treatment Intolerant n = 80	Treatment Naive n = 21
Black (n = 69, 62, 14)	44	43	11
Non-Black (n = 25, 18, 7)	16	18	5

Population analysed: Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.

Primary outcome: Number of Participants With One or More Adverse Events

Time frame: Week 48. Number. Unit: Participants

Measure	Treatment Experienced - Failing Current Therapy n = 97	Treatment Experienced - Intolerant To Current Therapy n = 88	Treatment Naive n = 21
Black (n = 70, 69, 14)	55	40	12
Non-Black (n = 27, 19, 7)	23	13	6

Primary outcome: Number of Participants Who Discontinued Due to an Adverse Event

Time frame: Week 48. Number. Unit: Participants

Measure	Treatment Experienced - Failing Current Therapy n = 97	Treatment Experienced - Intolerant To Current Therapy n = 88	Treatment Naive n = 21
Black (n = 70, 69, 14)	1	2	1
Non-black (n = 27, 19, 7)	0	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Experienced - Failing Current Therapy	15 of 97 (15.5%)	49 of 97 (50.5%)	Not reported
Treatment Experienced - Intolerant To Current Therapy	5 of 88 (5.7%)	26 of 88 (29.5%)	Not reported
Treatment Naive	2 of 21 (9.5%)	10 of 21 (47.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23351187Squires KE, Bekker LG, Eron JJ, Cheng B, Rockstroh JK, Marquez F, Kumar P, Thompson M, Campo RE, Mounzer K, Strohmaier KM, Lu C, Rodgers A, Jackson BE, Wenning LA, Robertson M, Nguyen BY, Sklar P; REALMRK Investigators. Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study. AIDS Res Hum Retroviruses. 2013 Jun;29(6):859-70. doi: 10.1089/AID.2012.0292. Epub 2013 Feb 26.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Human Immunodeficiency Virus

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: raltegravir in people with Human Immunodeficiency Virus, 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 2 inclusion and 5 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 Mar 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Apr 2012). 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?

Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 (time frame: Week 48). The study lists 3 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 NCT00764946, which also lists 1 linked publication.

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 Mar 2017.