NCT00762320

Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children

Completed NA Results posted Last updated 5 February 2014

What this trial tests

NA trial testing Low dose Kaletra tablets in HIV Infections in 8 participants. Completed in 1 July 2011.

Timeline

1 October 2008

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Phoenix Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 October 2008
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across United States

Drugs / interventions tested

• Low dose Kaletra tablets — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Phoenix Children's Hospital

Who can join

Adults 3 to 18, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Absolute CD4 and CD4 %
  Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
  Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deteriora
• Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid
  Time frame: Baseline
  Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.
• Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra
  Time frame: Baseline
  Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.
• Lopinavir AUC Ratio of Baseline:Week 4
  Time frame: Baseline, week 4
  Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.
• Viral Load (VL)
  Time frame: Baseline, Week 4, Week 12 and Week 24
  Number of participants who maintained their Viral load undetectable (\< 20 copies/ml) for the duration of the study
• Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks
  Time frame: 4 weeks
  Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs

Sponsor's own description

Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are HIV+. The liquid form is reported to have a very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parents who must enforce the medication regimen. The children are often well into their teens before they weigh enough to be able to take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now available. However, it is not known if the liquid and tablet act the same in children. The purpose of this study is to switch children from the baseline treatment with the liquid to the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will compare children pre-switch and post-switch in terms of how well their HIV is controlled . Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children currently well managed with a medications including liquid Kaletra will be invited to switch from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the parent and/or child will complete the satisfaction survey. In addition, at the switch and 1 month post switch, a day will be spent in clinic with 5 blood draws to see how much of the drug is in the blood stream at different times after the medicine is taken.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.