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

September 30, 2010
April 15, 2011
October 2010
February 2013   (final data collection date for primary outcome measure)
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%
Same as current
Complete list of historical versions of study NCT01213316 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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)
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

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adults with confirmed HIV-1 infection

HIV-1 Infection
Drug: Raltegravir
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96 weeks
HIV-1 infected participants
Adults with confirmed HIV-1 infection
Intervention: Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
265
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01213316
MK-0518-145
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck
Not Provided
Not Provided
Merck
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP