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CompletedNCT01213316WIPUpdated May 23, 2016Results posted

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 in HIV-1 Infection, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.

Sponsored by Merck Sharp & Dohme LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
451
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV-1 Infection

Keywords

  • HIV
  • antiretroviral
  • human immunodeficiency virus
  • Raltegravir
  • Adults with HIV-1 infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 451 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with confirmed HIV-1 infection

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
451 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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).

    Drug: Raltegravir

Interventions

  • DrugRaltegravir

    Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks

    Also known as: ISENTRESS®

  • DrugRaltegravir

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

    Also known as: ISENTRESS®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 48 weeks

  2. 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.

    Time frame: Baseline and 48 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 96 weeks

  2. 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.

    Time frame: Baseline and 96 weeks

  3. 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.

    Time frame: Baseline and 96 weeks

  4. 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.

    Time frame: Baseline and 48 weeks

  5. 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.

    Time frame: Baseline and 48 weeks

  6. 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.

    Time frame: Baseline and 48 weeks

  7. 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.

    Time frame: Baseline and 48 weeks

  8. 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.

    Time frame: Baseline

  9. 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.

    Time frame: Baseline

07

Results

Posted May 23, 2016

Participant flow

The Initial Cohort included participants \>=18 years old to receive treatment for 96 weeks. With the amendment, participants in the initial cohort \>=50 years old could continue for an additional 48-weeks observation (Prolonged Cohort), and participants \>=50 years old were newly enrolled to receive treatment for 48 weeks (Amendment Cohort).

Participant flow — Overall Study
MilestoneOverall Participants
Started451
Amendment cohort: prolonged participants48
Amendment cohort: newly enrolled179
Discontinued treatment before 48 weeks67
Initial cohort272
Completed451
Not completed0

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline and 48 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Percentage of participantsOverall Participants
Baseline50.8 (46.1 to 55.5)
48 weeks74.7 (70.4 to 78.7)
PrimaryPercentage 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.

Time frame:
Baseline and 48 weeks
Reported as:
Number · Percentage of participants
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Percentage of participantsAging Participants
Baseline62.1 (55.5 to 68.4)
48 weeks77.5 (71.5 to 82.8)
SecondaryPercentage 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.

Time frame:
Baseline and 96 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
Percentage of participantsInitial Cohort Participants
Baseline43.8 (37.8 to 49.9)
96 weeks68.0 (62.1 to 73.5)
SecondaryHIV-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.

Time frame:
Baseline and 96 weeks
Reported as:
Mean · Log10 Copies/mL
HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
Log10 Copies/mLInitial Cohort Participants
Baseline2.90 ± 1.65
96 weeks1.52 ± 0.43
SecondaryChange 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.

Time frame:
Baseline and 96 weeks
Reported as:
Mean · CD4+ T-cells/µL
Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
CD4+ T-cells/µLInitial Cohort Participants
Baseline461.9 ± 286.35
Change from Baseline at 96 weeks: n=216161.7 ± 225.98
SecondaryHIV-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.

Time frame:
Baseline and 48 weeks
Reported as:
Mean · Log10 Copies/mL
HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
Log10 Copies/mLAging Participants
Baseline2.28 ± 1.43
48 weeks1.50 ± 0.45
SecondaryChange 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.

Time frame:
Baseline and 48 weeks
Reported as:
Mean · CD4+ T-cells/µL
Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
CD4+ T-cells/µLAging Participants
Baseline534.4 ± 297.48
Change from Baseline at 48 weeks: n=20263.2 ± 183.43
SecondaryChange 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.

Time frame:
Baseline and 48 weeks
Reported as:
Mean · Percentage risk
Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Percentage riskAging Participants
Score at Baseline24.1 ± 17.5
Change from Baseline at 48 weeks: n=651.1 ± 10.9
SecondaryChange 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.

Time frame:
Baseline and 48 weeks
Reported as:
Mean · Percentage risk
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
Percentage riskAging Participants
Score at Baseline9.4 ± 8.7
Change from Baseline at 48 weeks: n=574.2 ± 9.5
SecondaryPercentage 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.

Time frame:
Baseline
Reported as:
Number · Percentage of participants
Percentage of Aging Participants With Concomitant Diseases at Baseline
Percentage of participantsAging Participants
Percentage of Aging Participants With Concomitant Diseases at Baseline93.8
SecondaryPercentage 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.

Time frame:
Baseline
Reported as:
Number · Percentage of participants
Percentage of Aging Participants Taking Concomitant Medications at Baseline
Percentage of participantsAging Participants
Percentage of Aging Participants Taking Concomitant Medications at Baseline74.9

Adverse events

Collected over Overall Participants: up to 48 weeks; Initial Cohort Participants: up to 96 weeks; Aging Participants: up to 48 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall Participants—34/451 (7.5%)0/451 (0%)
Initial Cohort Participants—25/272 (9.2%)0/272 (0%)
Aging Participants—17/227 (7.5%)0/227 (0%)
Most frequent serious events
Showing 10 of 56
Most frequent serious events
EventOverall ParticipantsInitial Cohort ParticipantsAging Participants
DizzinessNervous system disorders3/4510/2723/227
Lipase increasedInvestigations2/4512/2722/227
Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders2/4510/2722/227
Suicide attemptPsychiatric disorders2/4512/2720/227
Kaposi's sarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/4511/2721/227
Anaemia megaloblasticBlood and lymphatic system disorders1/4510/2721/227
ArrhythmiaCardiac disorders1/4510/2721/227
Chest painGeneral disorders1/4510/2721/227
GastroenteritisInfections and infestations1/4510/2721/227
AstheniaGeneral disorders1/4510/2721/227

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Overall Participants
Mean50.8 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female69
Male382
08

Study locations

No study locations are listed for this record.

09

References and documents

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. Erratum In: Int J STD AIDS. 2017 Jun;28(7):738. doi: 10.1177/0956462417702347. PubMed 28385065 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01213316
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 4, 2010
Start date
Oct 2010
Primary completion
Apr 2015
Completion
Apr 2015
Results posted
May 23, 2016
Last update
May 23, 2016

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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