HIV-1 InfectionWIPNCT01213316

A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)

An observational study of HIV-1 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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: Raltegravir
Type of treatment: Pill or oral medicine
How many people: 451 participants
Where: No sites listed yet
Study dates: Oct 2010to Apr 2015
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: Adults with confirmed HIV-1 infection

Who may be able to join

The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:
Is a minimum age of 18 years (adults) or 50 years (aging participants);
Is male or female;
Has confirmed infection with HIV-1 (positive HIV test according to appropriate standard practice);
Has commenced antiretroviral treatment with Raltegravir according to the recommendations made in the Summary of Product Characteristics at the time of enrollment on the study, or a maximum 6 months prior to enrollment on the study;
Has any cluster of differentiation (CD4) cell (specialized white blood cell) count upon enrollment on the study.

Who cannot join

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:
For which Raltegravir, or its ingredients, are contraindicated;
Has intolerance to Raltegravir, or its ingredients;
If female, is pregnant, breastfeeding, or is planning a pregnancy or egg donation during the study.

About this study

Official title: A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patients (≥ 50 Years) Under Conditions That Are Representative of the Nationwide Treatment of HIV-positive Patients in Germany

This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.

Conditions: HIV-1 Infection
Being tested: Raltegravir
Keywords: HIV, antiretroviral, human immunodeficiency virus, Raltegravir, Adults with HIV-1 infection
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.

RaltegravirDrug
Also called ISENTRESS®
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks
RaltegravirDrug
Also called ISENTRESS®
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks

Study groups in NCT01213316
Study group	Role	What they receive
Overall Participants		HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Receives: Drug: Raltegravir
Aging Participants		HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort). Receives: Drug: Raltegravir

What is being measured

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

Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Measured: Baseline and 48 weeks
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Measured: Baseline and 48 weeks

Secondary outcomes (9)

Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.
Measured: Baseline and 96 weeks
HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.
Measured: Baseline and 96 weeks
Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.
Measured: Baseline and 96 weeks
HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
Measured: Baseline and 48 weeks
Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.
Measured: Baseline and 48 weeks
Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Measured: Baseline and 48 weeks
Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Measured: Baseline and 48 weeks
Percentage of Aging Participants With Concomitant Diseases at Baseline
The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Measured: Baseline
Percentage of Aging Participants Taking Concomitant Medications at Baseline
The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Measured: Baseline

Timeline

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

Oct 2010Apr 2015

First posted4 Oct 2010 (estimated)
Study startOct 2010
Primary completionApr 2015
Study completionApr 2015

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 (5)Papers the sponsor has linked to this study.
Other trials for HIV-1 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 451 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01213316
Sponsor's protocol ID: 0518-145
Acronym: WIP
Status last verified: Apr 2016
First submitted: 30 Sep 2010
Last updated: 23 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Friis-Moller N, Thiebaut R, Reiss P, Weber R, Monforte AD, De Wit S, El-Sadr W, Fontas E, Worm S, Kirk O, Phillips A, Sabin CA, Lundgren JD, Law MG; DAD study group. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):491-501. doi: 10.1097/HJR.0b013e328336a150.
PubMed 20543702
D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
PubMed 18212285
Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
PubMed 1985385
Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation. 1991 Jan;83(1):356-62. doi: 10.1161/01.cir.83.1.356. No abstract available.
PubMed 1984895
Naumann U, Moll A, Schleehauf D, Lutz T, Schmidt W, Jaeger H, Funke B, Witte V. Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in HIV-infected patients, irrespective of age group, burden of comorbidities and concomitant medication: Real-life analysis of the German 'WIP' cohort. Int J STD AIDS. 2017 Aug;28(9):893-901. doi: 10.1177/0956462416679550. Epub 2016 Nov 14.
PubMed 28385065

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-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patients (≥ 50 Years) Under Conditions That Are Representative of the Nationwide Treatment of HIV-positive Patients in Germany
ClinicalTrials.gov ID: NCT01213316
Acronym / sponsor ID: WIP / 0518-145
Conditions: HIV-1 Infection
Keywords: HIV, antiretroviral, human immunodeficiency virus, Raltegravir, Adults with HIV-1 infection
Study type: Observational
Recruitment status: Completed
Enrolment: 451 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 4 Oct 2010 (estimated)
Results: Posted 23 May 2016

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Overall Participants	–	Drug: RaltegravirHIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Aging Participants	–	Drug: RaltegravirHIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults with confirmed HIV-1 infection

Key inclusion criteria (6 listed)

The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:
Is a minimum age of 18 years (adults) or 50 years (aging participants);
Is male or female;
Has confirmed infection with HIV-1 (positive HIV test according to appropriate standard practice);
Has commenced antiretroviral treatment with Raltegravir according to the recommendations made in the Summary of Product Characteristics at the time of enrollment on the study, or a maximum 6 months prior to enrollment on the study;

Key exclusion criteria (4 listed)

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:
For which Raltegravir, or its ingredients, are contraindicated;
Has intolerance to Raltegravir, or its ingredients;
If female, is pregnant, breastfeeding, or is planning a pregnancy or egg donation during the study.

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: ISENTRESS®Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks	Drug	Aging Participants
RaltegravirAlso: ISENTRESS®Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks	Drug	Overall Participants

Primary outcome

Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Time frame: Baseline and 48 weeks
The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Time frame: Baseline and 48 weeks
The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.

9 secondary outcomes

Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
Time frame: Baseline and 96 weeks
HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
Time frame: Baseline and 96 weeks
Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
Time frame: Baseline and 96 weeks
HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
Time frame: Baseline and 48 weeks
Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
Time frame: Baseline and 48 weeks
Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Time frame: Baseline and 48 weeks
Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Time frame: Baseline and 48 weeks
Percentage of Aging Participants With Concomitant Diseases at Baseline
Time frame: Baseline
Percentage of Aging Participants Taking Concomitant Medications at Baseline
Time frame: Baseline

Results and safety

Results posted to the registry on 23 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	451	451

Primary outcome: Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment

Time frame: Baseline and 48 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Overall Participants n = 451
Baseline	50.8 (46.1 to 55.5)
48 weeks	74.7 (70.4 to 78.7)

Population analysed: The analysis set included all participants who received at least one dose of raltegravir during the observation period.

Primary outcome: Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment

Time frame: Baseline and 48 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Aging Participants n = 227
Baseline	62.1 (55.5 to 68.4)
48 weeks	77.5 (71.5 to 82.8)

Population analysed: The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Overall Participants: up to 48 weeks; Initial Cohort Participants: up to 96 weeks; Aging Participants: up to 48 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Participants	34 of 451 (7.5%)	0 of 451 (0%)	Not reported
Initial Cohort Participants	25 of 272 (9.2%)	0 of 272 (0%)	Not reported
Aging Participants	17 of 227 (7.5%)	0 of 227 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20543702Friis-Moller N, Thiebaut R, Reiss P, Weber R, Monforte AD, De Wit S, El-Sadr W, Fontas E, Worm S, Kirk O, Phillips A, Sabin CA, Lundgren JD, Law MG; DAD study group. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):491-501. doi: 10.1097/HJR.0b013e328336a150.
Background: PubMed 18212285D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
Background: PubMed 1985385Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
Background: PubMed 1984895Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation. 1991 Jan;83(1):356-62. doi: 10.1161/01.cir.83.1.356. No abstract available.
Derived from this study: PubMed 28385065Naumann U, Moll A, Schleehauf D, Lutz T, Schmidt W, Jaeger H, Funke B, Witte V. Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in HIV-infected patients, irrespective of age group, burden of comorbidities and concomitant medication: Real-life analysis of the German 'WIP' cohort. Int J STD AIDS. 2017 Aug;28(9):893-901. doi: 10.1177/0956462416679550. Epub 2016 Nov 14.

Related trials for HIV-1 Infection

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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?

An observational study of HIV-1 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 6 inclusion and 4 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 23 May 2016. 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 23 May 2016). 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 an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment (time frame: Baseline and 48 weeks). The study lists 2 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 NCT01213316, which also lists 5 linked publications.

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 23 May 2016.