Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria (RALPIR)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Fritz Bredeek, MD, PhD, Metropolis Medical
ClinicalTrials.gov Identifier:
NCT01044771
First received: January 6, 2010
Last updated: May 8, 2015
Last verified: May 2015
Results First Received: January 20, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Proteinuria
Intervention: Drug: change from tenofovir to 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
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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
Change From Tenofovir to Raltegravir

Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day


Participant Flow:   Overall Study
    Change From Tenofovir to Raltegravir  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     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.
HIV

Reporting Groups
  Description
Change From Tenofovir to Raltegravir

Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients


Baseline Measures
    Change From Tenofovir to Raltegravir  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     20  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     14  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patients With Reduced or Resolved Proteinuria   [ Time Frame: 24 weeks ]

2.  Secondary:   Patients Without HIV Re-bound   [ Time Frame: 24 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Fritz Bredeek
Organization: Metropolis Medical
phone: 415 292 5477
e-mail: fritz@doctor.com


No publications provided


Responsible Party: Fritz Bredeek, MD, PhD, Metropolis Medical
ClinicalTrials.gov Identifier: NCT01044771     History of Changes
Other Study ID Numbers: RALPIR
Study First Received: January 6, 2010
Results First Received: January 20, 2014
Last Updated: May 8, 2015
Health Authority: United States: Institutional Review Board