NCT00564772

Brief Summary

This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_4 healthy

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

Study Start

First participant enrolled

November 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

November 27, 2007

Last Update Submit

March 19, 2019

Conditions

Healthy

Keywords

raltegravirlopinavirritonavirpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • drug levels of lopinavir, ritonavir, raltegravir

    2 months

Secondary Outcomes (1)

  • safety

    2 months

Study Arms (1)

single arm

EXPERIMENTAL

all subjects dosed the same

Drug: Raltegravir, lopinavir, ritonavir

Interventions

Raltegravir, lopinavir, ritonavirDRUG

4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.

Also known as: Isentress, Kaletra
single arm

Eligibility Criteria

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

You may qualify if:

  • Healthy, male or female, age 18-55.
  • Anti-HIV, anti-HCV, HBsAg negative.
  • Normal history and physical at screening.
  • Normal complete blood count, creatinine and ALT at screening.
  • Negative urine pregnancy test at screening.
  • BMI 18-30.

You may not qualify if:

  • Donated blood in the month before Day 1.
  • Participated in another research study in the month before Day 1.
  • Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
  • Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
  • Unwillingness to restrict coffee use to 6 or fewer cups of coffee during the study.
  • Unwillingness on the part of fertile female subjects to be abstinent or to use two effective birth control methods, one of which is a barrier method, for any vaginal intercourse.
  • Unwillingness to avoid use of any prescribed medication during the study
  • Allergy to RAL, lopinavir or ritonavir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prism Research Inc

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

Raltegravir PotassiumLopinavirRitonavirlopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Frank S Rhame, MD

    Allina Hospitals & Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

US(1)