Switch From Tenofovir to Raltegravir for Low Bone Mineral Density (TROP)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Holdsworth House Medical Practice
The Alfred
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT00939874
First received: July 14, 2009
Last updated: May 28, 2015
Last verified: May 2015
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Osteopenia
Osteoporosis
HIV Infections
Intervention: Drug: Raltegravir

  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
No text entered.

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 Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks

Participant Flow:   Overall Study
    Raltegravir  
STARTED     52  
Completed Week 48     37  
COMPLETED     32  
NOT COMPLETED     20  



  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.
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Reporting Groups
  Description
Raltegravir Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Baseline Measures
    Raltegravir  
Number of Participants  
[units: participants]
  37  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     35  
>=65 years     2  
Age  
[units: years]
Mean (Full Range)
  50   (30 to 70)  
Gender  
[units: participants]
 
Female     1  
Male     36  
Region of Enrollment  
[units: participants]
 
Australia     37  



  Outcome Measures
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1.  Primary:   Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips   [ Time Frame: from Baseline to Weeks 48 and 96 ]

2.  Secondary:   Percentage of Participants With HIV Viral Load <50 Copies/mL   [ Time Frame: from Baseline to Week 96 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Professor Andrew Carr
Organization: St Vincents Hospital
phone: +61 2 8382 3359
e-mail: andrew.carr@svha.org.au


No publications provided


Responsible Party: Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT00939874     History of Changes
Other Study ID Numbers: TROP
Study First Received: July 14, 2009
Results First Received: January 13, 2015
Last Updated: May 28, 2015
Health Authority: Australia: Therapeutic Goods Administration (TGA)