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Comparison of Liquid Kaletra and Low Dose Kaletra Tablets

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ClinicalTrials.gov Identifier: NCT00762320
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Information provided by (Responsible Party):
Janice Piatt, Phoenix Children's Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Low dose Kaletra tablets

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients weighing 15kg and able to swallow pills, currently taking liquid lpv/rtv were recruited from an outpatient pediatric HIV clinic from 4/1/2009 through 1/12/11

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Low Dose Kaletra

Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra

Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg

Participant Flow:   Overall Study
    Low Dose Kaletra

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Absolute CD4 and CD4 %   [ Time Frame: Baseline, 4 weeks, 12 weeks, 26 weeks ]

2.  Primary:   Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid   [ Time Frame: Baseline ]

3.  Primary:   Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra   [ Time Frame: Baseline ]

4.  Primary:   Lopinavir AUC Ratio of Baseline:Week 4   [ Time Frame: Baseline, week 4 ]

5.  Primary:   Viral Load (VL)   [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ]

6.  Primary:   Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks   [ Time Frame: 4 weeks ]

7.  Primary:   Lopinavir and Ritonavir AUC on Low Dose Tablet   [ Time Frame: 4 weeks ]

8.  Secondary:   Patient Satisfaction   [ Time Frame: Baseline, 1 month ]

9.  Secondary:   Symptoms Across All Patients   [ Time Frame: Baseline, 1 month, 3 months, 6 months ]

10.  Secondary:   Parent Satisfaction   [ Time Frame: Baseline, 4 week, 12 weeks and 24 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
Early termination leading to small number of subjects analyzed.

  More Information