A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

NCT ID: NCT00053638

Last Updated: 2010-10-04

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

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-10-31

Brief Summary

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This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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efavirenz

Intervention Type DRUG

tenofovir

Intervention Type DRUG

abacavir/lamivudine

Intervention Type DRUG

Other Intervention Names

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efavirenz tenofovir

Eligibility Criteria

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Inclusion Criteria

* Participants must be able to provide informed consent.
* Have documented HIV-1 infection.
* Have not received more than 14 days of prior treatment with antiretroviral drugs.
* Meet laboratory test criteria.
* Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
* Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion Criteria

* Enrolled in other HIV treatment studies.
* Pregnant or breastfeeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Phoenix, Arizona, United States

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Fountain Valley, 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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Denver, Colorado, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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

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

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

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, 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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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Minneapolis, Minnesota, United States

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Hillsborough, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Buffalo, New York, United States

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New York, 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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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Hampton, Virginia, United States

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Lynchburg, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Green Bay, Wisconsin, United States

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Countries

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United States

References

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Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier E. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8. doi: 10.1086/595296.

Reference Type DERIVED
PMID: 19032103 (View on PubMed)

Other Identifiers

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ESS30009

Identifier Type: -

Identifier Source: org_study_id