Kaletra-isentress Treatment Evaluation (KITE)

This study has been completed.
Sponsor:
Collaborators:
Abbott
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov Identifier:
NCT00700115
First received: June 16, 2008
Last updated: November 8, 2013
Last verified: November 2013
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Kaletra + Isentress
Drug: Pre-study antiretroviral 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
All subjects were recruited from an urban outpatient HIV clinic (the Grady Infectious Diseases Program Out-patient Clinic, Atlanta, Georgia) between June 2008 and January 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded if they were on medications that could interact with Protease inhibitors, had an active opportunistic infection, had renal and/or hepatic impairment, or were pregnant. Hepatitis B virus (HBV) co-infected patients receiving a nucleotide analogue for both HIV and HBV suppression were also excluded from enrollment.

Reporting Groups
  Description
Kaletra + Isentress Switched to Kaletra + Isentress
Standard HAART Pre-study standard HAART regimen

Participant Flow:   Overall Study
    Kaletra + Isentress     Standard HAART  
STARTED     40     20  
COMPLETED     39     19  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 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.
No text entered.

Reporting Groups
  Description
Kaletra + Isentress switched to Kaletra + Isentress
Standard HAART Pre-study standard HAART regimen
Total Total of all reporting groups

Baseline Measures
    Kaletra + Isentress     Standard HAART     Total  
Number of Participants  
[units: participants]
  40     20     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     40     20     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 9     48  ± 12     47  ± 10  
Gender  
[units: participants]
     
Female     14     8     22  
Male     26     12     38  
Region of Enrollment  
[units: participants]
     
United States     40     20     60  



  Outcome Measures
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1.  Primary:   Plasma Viral Loads (HIV-1 RNA PCR)   [ Time Frame: baseline to week 48 ]

2.  Secondary:   To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects   [ Time Frame: 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
The findings of the KITE study should be interpreted in the context of a pilot study with a small sample size. Furthermore, adverse effects were self-reported, and the lack of blinding may have introduced biases in the collection of the data.


  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. Igho Ofotokun
Organization: Emory University School of Medicine
phone: 404-616-0659
e-mail: iofotok@emory.edu


Publications of Results:

Responsible Party: Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov Identifier: NCT00700115     History of Changes
Other Study ID Numbers: IRB00006876, KITE-6876
Study First Received: June 16, 2008
Results First Received: June 7, 2012
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board