NCT00357721

Brief Summary

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1 hiv-infections

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

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

3 months

First QC Date

July 25, 2006

Last Update Submit

April 5, 2011

Conditions

HIV InfectionsProtease Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.

Secondary Outcomes (4)

  • Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID

  • Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform

  • Assess the effect of atazanavir BID on metabolic parameters

  • Assess the safety and tolerability of atazanavir when administered BID

Study Arms (3)

A1

ACTIVE COMPARATOR
Drug: Atazanavir Sulphate

A2

ACTIVE COMPARATOR
Drug: Atazanavir Sulphate

A3

ACTIVE COMPARATOR
Drug: Atazanavir Sulphate

Interventions

Atazanavir SulphateDRUG

Capsules, Oral, 200 mg, twice daily, 7 days.

Also known as: Reyataz
A1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Hamilton, New Jersey, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 27, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations

US(1)