Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects

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

2006-07-31

Study Completion Date

2006-09-30

Brief Summary

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The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

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Detailed Description

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Conditions

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HIV Infections Protease Inhibitor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate + Ritonavir

Intervention Type DRUG

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.

B

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate + Ritonavir + Efavirenz

Intervention Type DRUG

Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Interventions

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Atazanavir Sulphate + Ritonavir

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.

Intervention Type DRUG

Atazanavir Sulphate + Ritonavir + Efavirenz

Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz, Sustiva

Eligibility Criteria

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Inclusion Criteria

* BMI 18-30
* Men and women who are not of childbearing potential, ages 18-50 years, inclusive

Exclusion Criteria

* History of seizures or other central nervous system disorders (including migraine headaches)
* history of diagnosed mental illness or suicidal tendencies
* positive screening for Hep B surface antigen
* Hep C antibody
* HIV-1, -2

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes