Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)

An observational study of HIV Infections, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Raltegravir and ARV (non-raltegravir)
How many people: 482 participants
Where: No sites listed yet
Study dates: Jan 2010to Dec 2012
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participant Infected With HIV-1

Who may be able to join

Participant Infected With HIV-1.
Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

Who cannot join

Participant taking part in a clinical trial to assess raltegravir.
Participant in whom raltegravir treatment was started more than 30 days ago.

About this study

Official title: Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir

To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.

Conditions: HIV Infections
Being tested: Raltegravir, ARV (non-raltegravir)
Keywords: HIV
Medical subject headings: HIV Infections

What participants receive

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

RaltegravirDrug
Also called Isentress
Raltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily.
ARV (non-raltegravir)Drug
ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories.

Study groups in NCT01048671
Study group	Role	What they receive
Antiretroviral combination therapy including raltegravir		Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. Receives: Drug: Raltegravir; Drug: ARV (non-raltegravir)

What is being measured

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

Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.
Measured: Up to 25 months after start of raltegravir treatment
Percentage of Participants Responding to Treatment: All Treated Participants
Response to treatment was defined as a viral load <50 RNA copies/mL
Measured: 24 months after start of raltegravir treatment
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
Response to treatment was defined as a viral load <50 RNA copies/mL
Measured: 24 months after start of raltegravir treatment
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
Measured: Baseline and 24 months after start of raltegravir treatment
Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
Measured: Baseline and 24 months after start of raltegravir treatment

Secondary outcomes (1)

Number of Participants With at Least One Adverse Event
An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product.
Measured: Up to 25 months after start of raltegravir treatment

Timeline

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

Jan 2010Dec 2012

First posted14 Jan 2010 (estimated)
Study startJan 2010
Primary completionDec 2012
Study completionDec 2012

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 InfectionsStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01048671
Sponsor's protocol ID: 0518-138
Other IDs: MK0518-138
Acronym: RACING
Status last verified: Oct 2015
First submitted: 12 Jan 2010
Last updated: 30 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir
ClinicalTrials.gov ID: NCT01048671
Acronym / sponsor ID: RACING / 0518-138
Conditions: HIV Infections
Keywords: HIV
Study type: Observational
Recruitment status: Completed
Enrolment: 482 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 14 Jan 2010 (estimated)
Results: Posted 14 Feb 2014

Clinical summary

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

To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Antiretroviral combination therapy including raltegravir	–	Drug: Raltegravir, Drug: ARV (non-raltegravir)Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participant Infected With HIV-1

Key inclusion criteria (3 listed)

Participant Infected With HIV-1.
Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

Key exclusion criteria (2 listed)

Participant taking part in a clinical trial to assess raltegravir.
Participant in whom raltegravir treatment was started more than 30 days ago.

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
RaltegravirAlso: IsentressRaltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily.	Drug	Antiretroviral combination therapy including raltegravir
ARV (non-raltegravir)ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories.	Drug	Antiretroviral combination therapy including raltegravir

Primary outcome

Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Time frame: Up to 25 months after start of raltegravir treatment
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.
Percentage of Participants Responding to Treatment: All Treated Participants
Time frame: 24 months after start of raltegravir treatment
Response to treatment was defined as a viral load <50 RNA copies/mL
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
Time frame: 24 months after start of raltegravir treatment
Response to treatment was defined as a viral load <50 RNA copies/mL
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
Time frame: Baseline and 24 months after start of raltegravir treatment
Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
Time frame: Baseline and 24 months after start of raltegravir treatment

1 secondary outcome

Number of Participants With at Least One Adverse Event
Time frame: Up to 25 months after start of raltegravir treatment

Results and safety

Results posted to the registry on 14 Feb 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
ARV naïve at Baseline	66	66
Suppressed at Baseline	264	263
Virological Failure at Baseline	152	151

Primary outcome: Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir

Time frame: Up to 25 months after start of raltegravir treatment. Number. Unit: Percentage of participants

Measure	Antiretroviral Combination Therapy Including Raltegravir n = 477
FTC/TDF + raltegravir	44.4
3TC/ABC + raltegravir	14.0
Other 2 NRTIs + raltegravir	1.3
Mulitple (>=3 ) ARV therapies + raltegravir	15.7
Protease inhibitor + raltegravir	8.8
Other strategies (each <5%)	15.7

Population analysed: Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.

Primary outcome: Percentage of Participants Responding to Treatment: All Treated Participants

Time frame: 24 months after start of raltegravir treatment. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	ARV naïve at Baseline n = 52	Suppressed at Baseline n = 230	Virological Failure at Baseline n = 125	All Participants n = 407
Value	94.2 (87.9 to 100.6)	94.3 (91.4 to 97.3)	71.2 (63.3 to 79.1)	87.2 (84.0 to 90.5)

Population analysed: All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.

Primary outcome: Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24

Time frame: 24 months after start of raltegravir treatment. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	ARV naïve at Baseline n = 39	Suppressed at Baseline n = 194	Virological Failure at Baseline n = 94	All Participants n = 327
Value	94.9 (87.9 to 101.8)	95.4 (92.4 to 98.3)	77.7 (69.2 to 86.1)	90.2 (87.0 to 93.4)

Population analysed: All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.

Primary outcome: Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants

Time frame: Baseline and 24 months after start of raltegravir treatment. Mean (95% Confidence Interval). Unit: cells/mm^3

Measure	ARV naïve at Baseline n = 55	Suppressed at Baseline n = 229	Virological Failure at Baseline n = 123	All Participants n = 407
Value	260.58 (208.75 to 312.41)	47.97 (19.57 to 76.36)	149.98 (113.71 to 186.26)	107.53 (85.80 to 129.29)

Population analysed: All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antiretroviral Combination Therapy Including Raltegravir	66 of 480 (13.8%)	27 of 480 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, 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 3 inclusion and 2 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 30 Oct 2015. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 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 Receiving Antiretroviral Treatments Administered With Raltegravir (time frame: Up to 25 months after start of raltegravir treatment). The study lists 5 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 NCT01048671.

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 30 Oct 2015.