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 AM1) (Wirksamkeit Von Isentress® Unter Praxisbedingungen) (WIP)
This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01213316
First received: September 30, 2010
Last updated: May 21, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Merck:
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: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (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 More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01213316 History of Changes |
| Other Study ID Numbers: | MK-0518-145 |
| Study First Received: | September 30, 2010 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Merck:
|
HIV antiretroviral human immunodeficiency virus Raltegravir Adults with HIV-1 infection |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013