A Study to Assess the Efficacy of Raltegravir, 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) (WIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01213316
First received: September 30, 2010
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
HIV-1 Infection
Drug: Raltegravir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The proportion of participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of Raltegravir treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The proportion of aging participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of Raltegravir treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of participants with an HIV-1 viral load < 50 copies/mL after 96 weeks of Raltegravir treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • HIV-1 viral load in participants over a period of 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in CD4+ T-cell counts over a period of 96 weeks [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
  • HIV-1 viral load in aging participants over a period of 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in CD4+ T-cell counts in aging participants over a period of 48 weeks [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Framingham Risk Scores for cardiovascular disease in aging participants and changes from baseline [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Scores for cardiovascular disease in aging participants and changes from baseline [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Number of aging participants with a comorbidity [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of aging participants taking a concomitant medication [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 443
Study Start Date: October 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-1 infected participants
Adults ≥18 years with confirmed HIV-1 infection
Drug: Raltegravir
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96 weeks
Other Name: ISENTRESS®
HIV-1 infected aging participants

Adults ≥50 years with confirmed HIV-1 infection

Newly enrolled aging participants - Amendment 1, plus participants from Cohort 1, who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment.

Drug: Raltegravir
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 weeks
Other Name: ISENTRESS®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with confirmed HIV-1 infection

Criteria

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

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 are planning a pregnancy or egg donation during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01213316     History of Changes
Other Study ID Numbers: 0518-145
Study First Received: September 30, 2010
Last Updated: August 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:
HIV
antiretroviral
human immunodeficiency virus
Raltegravir
Adults with HIV-1 infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014