Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

NCT ID: NCT00135382

Last Updated: 2010-02-17

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

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-10-31

Brief Summary

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The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Detailed Description

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Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Videx EC

Intervention Type DRUG

Epivir

Intervention Type DRUG

Sustiva

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented HIV infection
* ≥ 18 years of age and weight at least 40kg
* Two plasma HIV RNA levels \< 50 copies/mL during the qualification and screening period
* Patients receiving a PI and ≥ 2 NRTIs

Exclusion Criteria

* Pregnancy or breastfeeding
* Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
* Active AIDS-defining opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Fountain Valley, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Tarzana, California, United States

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West Hollywood, California, United States

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Denver, Colorado, United States

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Norwalk, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Safety Harbor, Florida, United States

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South Miami, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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East Orange, New Jersey, United States

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Newark, New Jersey, United States

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Union, New Jersey, United States

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Brooklyn, New York, United States

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Manhasset, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Valhalla, New York, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Hampton, Virginia, United States

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Milwaukee, Wisconsin, United States

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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Countries

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United States Puerto Rico

Other Identifiers

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AI266-406

Identifier Type: -

Identifier Source: org_study_id

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