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Trial record 85 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

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.
 
ClinicalTrials.gov Identifier: NCT00700115
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : October 22, 2013
Last Update Posted : December 12, 2014
Sponsor:
Collaborators:
Abbott
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
Enrollment 60
Recruitment Details 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 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.
Arm/Group Title Kaletra + Isentress Standard HAART
Hide Arm/Group Description Switched to Kaletra + Isentress Pre-study standard HAART regimen
Period Title: Overall Study
Started 40 20
Completed 39 19
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             1
Arm/Group Title Kaletra + Isentress Standard HAART Total
Hide Arm/Group Description switched to Kaletra + Isentress Pre-study standard HAART regimen Total of all reporting groups
Overall Number of Baseline Participants 40 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
20
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 20 participants 60 participants
46  (9) 48  (12) 47  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 20 participants 60 participants
Female
14
  35.0%
8
  40.0%
22
  36.7%
Male
26
  65.0%
12
  60.0%
38
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 20 participants 60 participants
40 20 60
1.Primary Outcome
Title Plasma Viral Loads (HIV-1 RNA PCR)
Hide Description Percentage subjects with undetectable Plasma viral loads
Time Frame baseline to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Kaletra + Isentress Standard HAART
Hide Arm/Group Description:
switched to Kaletra + Isentress
Pre-study standard HAART regimen
Overall Number of Participants Analyzed 40 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
92.7
(83 to 100)
88
(75 to 100)
2.Secondary Outcome
Title To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Kaletra + Isentress Standard HAART
Hide Arm/Group Description:
switched to Kaletra + Isentress
Pre-study standard HAART regimen
Overall Number of Participants Analyzed 35 19
Mean (Standard Error)
Unit of Measure: mg/dL
238.1  (19.9) 133.3  (27.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Kaletra + Isentress Standard HAART
Hide Arm/Group Description switched to Kaletra + Isentress Pre-study standard HAART regimen
All-Cause Mortality
Kaletra + Isentress Standard HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Kaletra + Isentress Standard HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Kaletra + Isentress Standard HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/19 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Igho Ofotokun
Organization: Emory University School of Medicine
Phone: 404-616-0659
EMail: iofotok@emory.edu
Layout table for additonal information
Responsible Party: Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov 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