NCT00985543

Brief Summary

The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval, following administration to male and female HIV-negative healthy volunteers of:

  1. 1.Lopinavir/ritonavir 400/100 mg twice daily
  2. 2.Lopinavir/ritonavir 200/150 mg twice daily
  3. 3.Lopinavir/ritonavir 200/50 mg twice daily

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 29, 2011

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

September 25, 2009

Results QC Date

February 4, 2011

Last Update Submit

March 2, 2011

Conditions

Acquired Immunodeficiency Syndrome

Keywords

HIVARTHAARTPharmacokineticsLopinavir/ritonavirLower dose selection

Outcome Measures

Primary Outcomes (1)

  • Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h).

    Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.

    at the end of each 7-day dosing phase

Secondary Outcomes (1)

  • Adverse Events

    Up to 11 weeks from screening to final study visit

Study Arms (3)

LPV/r 400/100 mg

ACTIVE COMPARATOR

Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))

Drug: lopinavir/ritonavir

LPV/r 200/150 mg

EXPERIMENTAL

Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)

Drug: lopinavir/ritonavir

LPV/r 200/50 mg

EXPERIMENTAL

Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)

Drug: lopinavir/ritonavir

Interventions

lopinavir/ritonavirDRUG

Each participant received three sequential doses of lopinavir/ritonavir: 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID), and 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.

Also known as: Meltrex, Ritonavir
LPV/r 200/150 mgLPV/r 200/50 mgLPV/r 400/100 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
  • Male or non-pregnant, non-lactating females
  • Between 18 to 65 years, inclusive
  • Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

You may not qualify if:

  • Any significant acute or chronic medical illness
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
  • Positive blood screen for hepatitis B core and/or C antibodies and/or hepatitis B surface antigen
  • Positive blood screen for HIV-1 and/or 2 antibodies
  • Current or recent (within 3 months) gastrointestinal disease
  • Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
  • Exposure to any investigational drug or placebo within 3 months of first dose of study drug
  • Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within one week of first dose of study drug and for the duration of the study
  • Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
  • Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
  • Previous allergy to any of the constituents of the pharmaceuticals administered in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Stephen's Centre, Chelsea and Westminster Hospital

London, SW10 9TH, United Kingdom

Location

Related Publications (1)

  • Jackson A, Hill A, Puls R, Else L, Amin J, Back D, Lin E, Khoo S, Emery S, Morley R, Gazzard B, Boffito M. Pharmacokinetics of plasma lopinavir/ritonavir following the administration of 400/100 mg, 200/150 mg and 200/50 mg twice daily in HIV-negative volunteers. J Antimicrob Chemother. 2011 Mar;66(3):635-40. doi: 10.1093/jac/dkq468. Epub 2010 Dec 17.

    PMID: 21172791DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

LopinavirRitonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Results Point of Contact

Title
Dr Marta Boffito
Organization
St Stephens Centre, Chelsea and Westminster Hospital
marta.boffito@chelwest.nhs.uk
+44 2088 466 507

Study Officials

  • Marta Boffito, MD PhD

    Chelsea and Westminster Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 29, 2011

Results First Posted

March 29, 2011

Record last verified: 2011-03

Locations

GB(1)