Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00766818 · ClinicalTrials.gov registry record · Phase 1

The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00766818: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT00766818 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00766818, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting \~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).

Interventions

  • DRUG Kaletra

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2007-01
Est. Completion 2010-03
Phase Phase 1

What the finished NCT00766818 record still lists

NCT00766818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Kaletra is the first listed.

NCT00766818 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00766818 about?

NCT00766818 is a clinical study titled "The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet". In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting \~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase you...

What is the current status of trial NCT00766818?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-01. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00766818?

The interventions under investigation include: Kaletra (DRUG).

Who is sponsoring clinical trial NCT00766818?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00766818's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02602769 · 12 participants

    Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome

  • NCT02605421 · 12 participants · Phase 2

    Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

  • NCT02619448 · 12 participants · Early Phase 1

    Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC

  • NCT03311503 · 12 participants · Phase 1

    Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00766818, the US trial registry maintained by the National Library of Medicine. NCT00766818 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.