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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749580
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : July 22, 2014
Last Update Posted : December 17, 2014
Merck Sharp & Dohme Corp.
St. Joseph's Hospital, Florida
Information provided by (Responsible Party):
University of South Florida

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Virus Diseases
Intervention: Drug: Switch NRTIs as a Backbone to Raltegravir

  Participant Flow

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
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 
Lost to Follow-up                4                8 
Adverse Event                0                1 
[1] September 2008
[2] December 2010

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 21   25   46 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   21   25   46 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 45  (9)   49  (8)   47  (9) 
[Units: Participants]
Female   6   6   12 
Male   15   19   34 
Region of Enrollment 
[Units: Participants]
United States   21   25   46 

  Outcome Measures

1.  Primary:   Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 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

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

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

Responsible Party: University of South Florida Identifier: NCT00749580     History of Changes
Obsolete Identifiers: NCT00717964
Other Study ID Numbers: Merck-MK0518
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: March 27, 2014
Results First Posted: July 22, 2014
Last Update Posted: December 17, 2014