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Trial record 5 of 39 for:    " September 01, 2010":" October 01, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
  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. 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


Condition Intervention
HIV-1 Infection
 Drug: Raltegravir

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

Resource links provided by NLM:

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 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%


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 265
Study Start Date: October 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-1 infected participants
Adults with confirmed HIV-1 infection
 Drug: Raltegravir
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96 weeks

  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;
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213316

Locations
Germany
Msd Sharp & Dohme Gmbh
Haar, Germany, 85540
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01213316     History of Changes
Other Study ID Numbers: MK-0518-145
Study First Received: September 30, 2010
Last Updated: April 15, 2011
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 19, 2013