Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir

NCT ID: NCT00120393

Last Updated: 2010-02-05

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

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-05-31

Brief Summary

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Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G1

Group Type ACTIVE_COMPARATOR

atazanavir/ritonavir +2 NRTIs (immediate Switch Group)

Intervention Type DRUG

Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.

G2

Group Type ACTIVE_COMPARATOR

LPV/r +2 NRTIs (Delayed/optional Switch Group)

Intervention Type DRUG

Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.

Interventions

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atazanavir/ritonavir +2 NRTIs (immediate Switch Group)

Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.

Intervention Type DRUG

LPV/r +2 NRTIs (Delayed/optional Switch Group)

Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.

Intervention Type DRUG

Other Intervention Names

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Reyataz

Eligibility Criteria

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Inclusion Criteria

* HIV positive
* LPV/RTV-based HAART for at least 6 months
* HIV-1 RNA less than 50c/mL (confirmed)
* Non-HDL higher than 160 mg/dL
* CD4 of at least 50 cells/mL

Exclusion Criteria

* Use of lipid-lowering agents
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Phoenix, Arizona, United States

Site Status

Local Institution

Bakersfield, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Miami, Florida, United States

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Boston, Massachusetts, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Hamilton, Ontario, Canada

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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AI424-100

Identifier Type: -

Identifier Source: org_study_id

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