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DDI HV (ATV - Merck)

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Raltegravir

Atazanavir

Atazanavir + Raltegravir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antivirals / HIV

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

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.
Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

Sites / Locations

Bristol-Myers Squibb Clinical Pharmacology Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety Assessments

Pharmacokinetic Assessments

Secondary Outcome Measures

Full Information

NCT ID

NCT00518297

First Posted

August 17, 2007

Last Updated

February 3, 2010

Sponsor

Bristol-Myers Squibb

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00518297

Brief Title

DDI HV (ATV - Merck)

Official Title

Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Antivirals / HIV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Intervention Description

Tablet, Oral, 400 mg, twice daily for 5 Days

Intervention Type

Drug

Intervention Name(s)

Atazanavir

Other Intervention Name(s)

Reyataz

Intervention Description

Capsule, Oral, 300 mg, twice daily for 7 Days

Intervention Type

Drug

Intervention Name(s)

Atazanavir + Raltegravir

Other Intervention Name(s)

Reyataz

Intervention Description

Capsule/Tablet, Oral, 300/400, twice daily for 14 Days

Primary Outcome Measure Information:

Title

Safety Assessments

Time Frame

Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge

Title

Pharmacokinetic Assessments

Time Frame

Days 5, 12, and 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m² Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test Exclusion Criteria: 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. Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Bristol-Myers Squibb Clinical Pharmacology Unit

City

Hamilton

State/Province

New Jersey

ZIP/Postal Code

08690

Country

United States

12. IPD Sharing Statement

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DDI HV (ATV - Merck)

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