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
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Drug: Kaletra + Isentress
Drug: Pre-study antiretroviral regimen
|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.|
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.