NCT00420355

Brief Summary

The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

6 months

First QC Date

January 9, 2007

Last Update Submit

February 5, 2009

Conditions

HIV Infection

Keywords

antiretroviral therapyprotease inhibitorsdrug interactionsHIV infectionacquired immunodeficiency syndromeTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir

    Day 6, Day 12 or 16, Day 20

Secondary Outcomes (1)

  • Safety (e.g., GI tolerance, lab abnormalities, ECG changes)

    Day 6, Day 12 or Day 16, Day 20

Study Arms (2)

Arm A

EXPERIMENTAL

Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.

Drug: lopinavir/ritonavir

Arm B

EXPERIMENTAL

Subjects on lopinavir/ritonavir will add atazanavir.

Drug: atazanavir

Interventions

atazanavirDRUG

Atazanavir 300 mg daily on Days 6-12.

Also known as: Reyataz 300 mg capsules
Arm B
lopinavir/ritonavirDRUG

Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.

Also known as: Kaletra 200 mg/50 mg tablets
Arm A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-seropositive
  • Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
  • If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study

You may not qualify if:

  • HIV-1 RNA \> 400 copies/mL if currently receiving antiretroviral therapy
  • Concurrent use of CYP450 inhibitors or inducers
  • Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
  • Concurrent use of medications known to interact with ritonavir or atazanavir
  • Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
  • Presence of conduction abnormalities on electrocardiogram
  • Women who are pregnant or breastfeeding
  • Laboratory Abnormalities at baseline:
  • Aminotransferases \> 3x ULN
  • Serum bilirubin \> 5x ULN
  • Serum creatinine \> 1.5x ULN
  • Hemoglobin concentration \< 8.0 g/dL
  • Absolute neutrophil count \< 800 cells/μL
  • Platelet count \< 50,000 cells/μL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUHSC General Clinical Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Rathbun CR, Liedtke MD, Blevins SM, Harrison D, Lockhart SM, Salvaggio M, Acosta EP. Electrocardiogram abnormalities with atazanavir and lopinavir/ritonavir. HIV Clin Trials. 2009 Sep-Oct;10(5):328-36. doi: 10.1310/hct1005-328.

    PMID: 19906626DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Atazanavir SulfateLopinavirlopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsPyrimidinonesPyrimidines

Study Officials

  • R. Chris Rathbun, Pharm.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2007

Study Completion

September 1, 2008

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

US(1)