DDI HV (ATV - Merck)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Raltegravir

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Atazanavir

Intervention Type DRUG

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

3

Group Type ACTIVE_COMPARATOR

Atazanavir + Raltegravir

Intervention Type DRUG

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

Interventions

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Raltegravir

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

Intervention Type DRUG

Atazanavir

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

Intervention Type DRUG

Atazanavir + Raltegravir

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

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes