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)

NCT01213316 | Completed Results

• 1 other identifier: 0518-145
• Study Type: observational
• Target: 451
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV-1 Infection

Keywords

HIV; antiretroviral; human immunodeficiency virus; Raltegravir; Adults with HIV-1 infection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline and 96 weeks

• HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment

  Baseline and 96 weeks

• Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment

  Baseline and 96 weeks

• HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment

  Baseline and 48 weeks

• Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment

  Baseline and 48 weeks

Study Arms (2)

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

Raltegravir DRUG

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

Also known as: ISENTRESS®

Aging Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with confirmed HIV-1 infection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (5)

• 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.

  PMID: 20543702 BACKGROUND

• 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.

  PMID: 18212285 BACKGROUND

• 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.

  PMID: 1985385 BACKGROUND

• 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.

  PMID: 1984895 BACKGROUND

• 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.

  PMID: 28385065 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 23, 2016
• Results First Posted: May 23, 2016

Record last verified: 2016-04