Kaletra-isentress Treatment Evaluation (KITE)

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: NCT00700115
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : October 22, 2013
Last Update Posted : December 12, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Kaletra + Isentress
Drug: Pre-study antiretroviral regimen

  Participant Flow

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
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 
Withdrawal by Subject                1                0 
Lost to Follow-up                0                1 

  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
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 
Overall Participants Analyzed 
[Units: Participants]
 40   20   60 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   40   20   60 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 46  (9)   48  (12)   47  (10) 
[Units: Participants]
Female   14   8   22 
Male   26   12   38 
Region of Enrollment 
[Units: Participants]
United States   40   20   60 

  Outcome Measures

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

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

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

Publications of Results:

Responsible Party: Ighovwerha Ofotokun, Emory University Identifier: NCT00700115     History of Changes
Other Study ID Numbers: IRB00006876
KITE-6876 ( Other Identifier: Other )
First Submitted: June 16, 2008
First Posted: June 18, 2008
Results First Submitted: June 7, 2012
Results First Posted: October 22, 2013
Last Update Posted: December 12, 2014