Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)

This study has been terminated.
(The trial was terminated early due to slow recruitment.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01814722
First received: March 18, 2013
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: October 6, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adults with human immunodeficiency virus (HIV) who were switching from first-line antiretroviral regimens to a second-line regimen were recruited at 48 academic and community-based practices in the U.S.A.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Raltegravir + 2 NRTIs Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
NNRTI + 2 NRTIs Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
PI + 2 NRTIs Participants were treated with two NRTIs and a protease inhibitor (PI).

Participant Flow:   Overall Study
    Raltegravir + 2 NRTIs     NNRTI + 2 NRTIs     PI + 2 NRTIs  
STARTED     36     21     6  
COMPLETED     36     21     6  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Gender and Age data for one participant from the Raltegravir, and two participants from the NNRTI groups were missing, resulting in a n = 60.

Reporting Groups
  Description
Raltegravir + 2 NRTIs Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
NNRTI + 2 NRTIs Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
PI + 2 NRTIs Participants were treated with two NRTIs and a protease inhibitor (PI).
Total Total of all reporting groups

Baseline Measures
    Raltegravir + 2 NRTIs     NNRTI + 2 NRTIs     PI + 2 NRTIs     Total  
Number of Participants  
[units: participants]
  35     19     6     60  
Age  
[units: Years]
Mean ± Standard Deviation
  46.7  ± 8.9     45.2  ± 13.8     48.8  ± 4.1     46.3  ± 10.3  
Gender  
[units: Participants]
       
Female     14     2     0     16  
Male     21     17     6     44  



  Outcome Measures
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1.  Primary:   Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores   [ Time Frame: Week 4 Follow-up ]

2.  Secondary:   Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)   [ Time Frame: Baseline and Week 4 Follow-up ]

3.  Secondary:   Change From Baseline in HIV Symptom Index (HIV-SI)   [ Time Frame: Baseline and Week 4 Follow-up ]

4.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI)   [ Time Frame: Baseline and Week 4 Follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01814722     History of Changes
Other Study ID Numbers: 0518-266
Study First Received: March 18, 2013
Results First Received: October 6, 2014
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration