A Study to Assess the Efficacy of Raltegravir, Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeitvon)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Merck.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01213316

First received: September 30, 2010

Last updated: April 15, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 30, 2010
Last Updated Date	April 15, 2011
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 30, 2010)	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 participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of Raltegravir treatment will be determined, to be evaluated against an expected response rate of 45%
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01213316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 30, 2010)	The proportion of participants with an HIV-1 viral load < 50 copies/mL 96 weeks of Raltegravir treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] The proportion of participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of Raltegravir treatment will be determined, to be evaluated against an expected response rate of 45% Immunologic data regarding viral load count [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Immunologic data regarding viral load count will be evaluated for the 96 week treatment period, changes over time will be described Immunologic data regarding lymphocyte count [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Immunologic data regarding viral load count will be evaluated for the 96 week treatment period, changes over time will be described
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Assess the Efficacy of Raltegravir, Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145)
Official Title ^ICMJE	Non-Interventional Study (NIS) 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 Under Clinical Conditions
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. Participants who stop taking Raltegravir before the end of the 96-week period will be followed up for three months after discontinuing the drug. The primary objective is to determine the proportion of participants with an HIV-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adults with confirmed HIV-1 infection
Condition ^ICMJE	HIV-1 Infection
Intervention ^ICMJE	Drug: Raltegravir Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96 weeks
Study Group/Cohort (s)	HIV-1 infected participants Adults with confirmed HIV-1 infection Intervention: Drug: Raltegravir
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	265
Estimated Completion Date	February 2013
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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; 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 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01213316
Other Study ID Numbers ^ICMJE	MK-0518-145
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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