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NCT00762320 · ClinicalTrials.gov registry record · NA
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
A NA study, sponsored by Phoenix Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT00762320: Completed NA study, sponsored by Phoenix Children's Hospital.
NCT00762320 is a NA study that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00762320, a NA study, has completed, sponsored by Phoenix Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.
Interventions
- DRUG Low dose Kaletra tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-07 |
| Phase | NA |
What the finished NCT00762320 record still lists
NCT00762320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Low dose Kaletra tablets is the first listed.
NCT00762320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00762320 about?
NCT00762320 is a clinical study titled "Comparison of Liquid Kaletra and Low Dose Kaletra Tablets". 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 ...
What is the current status of trial NCT00762320?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2008-10. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00762320?
The interventions under investigation include: Low dose Kaletra tablets (DRUG).
Who is sponsoring clinical trial NCT00762320?
This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00762320's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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