A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
St. Joseph's Hospital, Florida
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00749580
First received: September 5, 2008
Last updated: June 24, 2014
Last verified: June 2014
Results First Received: March 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Virus Diseases
HIV
Intervention: Drug: Switch NRTIs as a Backbone to Raltegravir in HIV-Infected Patients from a Stable Boosted PI Regimen

  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
Participants were recruited from the HIllsborough County Health Department, and Tampa Care Clinic, Tampa, Florida.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Per the inclusion and exclusion criteria

Reporting Groups
  Description
Switched Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
Controlled Group 2 Continue the same regimen without change

Participant Flow:   Overall Study
    Switched     Controlled  
STARTED     21 [1]   25  
COMPLETED     17 [2]   16  
NOT COMPLETED     4     9  
Lost to Follow-up                 4                 8  
Adverse Event                 0                 1  
[1] September 2008
[2] December 2010



  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.
No text entered.

Reporting Groups
  Description
1: Boosted PI+RAL Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
2: Boosted PI+NRTIs Group 2 Continue the same regimen without change
Total Total of all reporting groups

Baseline Measures
    1: Boosted PI+RAL     2: Boosted PI+NRTIs     Total  
Number of Participants  
[units: participants]
  21     25     46  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     25     46  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 9     49  ± 8     47  ± 9  
Gender  
[units: participants]
     
Female     6     6     12  
Male     15     19     34  
Region of Enrollment  
[units: participants]
     
United States     21     25     46  



  Outcome Measures
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1.  Primary:   The Purpose of This Study is to Measure Number of Patients With Suppressed Viral Load(<75 Copies/ml)in ra;Tergravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen   [ Time Frame: at 24weeks for each patient ]

2.  Secondary:   Virologic Suppression of < 75 Copies/ml at 48 Weeks   [ Time Frame: at 48 weeks for each patient ]


  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
This is a pilot study and has a small sample size.


  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: Charurut Somboonwit, MD
Organization: USF Health
phone: 813 3078067
e-mail: csomboon@health.usf.edu


No publications provided


Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00749580     History of Changes
Obsolete Identifiers: NCT00717964
Other Study ID Numbers: Merck-MK0518
Study First Received: September 5, 2008
Results First Received: March 27, 2014
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board