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Pilot Study of a Raltegravir Based NRTI Sparing Regimen

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00814879
First received: December 18, 2008
Last updated: January 4, 2016
Last verified: January 2016
Results First Received: November 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immune Deficiency Syndrome
AIDS
Human Immunodeficiency Virus
HIV Infections
Interventions: Drug: Raltegravir
Drug: Atazanavir
Other: Standard treatment 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
A total of 60 patients were randomized in this pilot study; 30 in each arm. Two patients randomized to stay on their N(t)NRTIs+PIr regimen were randomization failures as the patients did not for return for their baseline visit.

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
N(t)RTI(s) + PI/r

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

RAL + ATV

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID


Participant Flow for 2 periods

Period 1:   By Week 24
    N(t)RTI(s) + PI/r   RAL + ATV
STARTED   28   30 
COMPLETED   27   29 
NOT COMPLETED   1   1 
Cancer Diagnosis                1                0 
Incarceration                0                1 

Period 2:   By Week 48
    N(t)RTI(s) + PI/r   RAL + ATV
STARTED   27   29 
COMPLETED   25   26 
NOT COMPLETED   2   3 
Lost to Follow-up                2                2 
Death                0                1 



  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
N(t)NRTI + Plr

N(t)RTI(s) based backbone & PI/r

Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI

RAL + ATV

Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID

Raltegravir: 400 mg BID

Atazanavir: 300 mg BID

Total Total of all reporting groups

Baseline Measures
   N(t)NRTI + Plr   RAL + ATV   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   30   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.5  (9.8)   48.0  (9.7)   48.2  (9.6) 
Gender 
[Units: Participants]
     
Female   5   6   11 
Male   23   24   47 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   6   9   15 
White   21   20   41 
More than one race   0   0   0 
Unknown or Not Reported   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   28   30   58 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Reaching Virologic Failure at Week 48.   [ Time Frame: 48 Weeks ]

2.  Secondary:   Number of Patients With < 400 Copies HIV RNA/mL at Week 48   [ Time Frame: 48 weeks ]

3.  Secondary:   CD4+ Cell Count   [ Time Frame: Weeks 24 ]

4.  Secondary:   CD4+ Cell Count   [ Time Frame: Week 48 ]

5.  Secondary:   Cholesterol   [ Time Frame: baseline, week 24, week 48 ]

6.  Secondary:   Mean Change in Total Bilirubin (mg/dL) From Baseline   [ Time Frame: baseline and 48 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael J. Kozal
Organization: Yale University School of Medicine: Internal Medicine: Infectious Diseases: AIDS Care Program / Viral Hepatitis Program
phone: (203)737-4040
e-mail: michael.kozal@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00814879     History of Changes
Other Study ID Numbers: 0811004448
Yale-No Nukes
Study First Received: December 18, 2008
Results First Received: November 23, 2015
Last Updated: January 4, 2016
Health Authority: United States: Institutional Review Board