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Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV

NCT ID: NCT00244712

Last Updated: 2010-06-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-04-30

Brief Summary

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This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks

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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

DOUBLE

Participants Investigators

Study Groups

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ABC/3TC

The intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir.

Group Type EXPERIMENTAL

abacavir/lamivudine

Intervention Type DRUG

The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.

TDF/FTC

The intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

Group Type ACTIVE_COMPARATOR

emtricitabine/tenofovir

Intervention Type DRUG

The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

Interventions

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emtricitabine/tenofovir

The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

Intervention Type DRUG

abacavir/lamivudine

The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males as females at least 18 years old. (A female is eligible to enter and participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.)
* Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any NRTI and no prior therapy with either a PI or NNRTI).
* Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL at screening.
* Subject is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion Criteria

* Subject has an active or acute CDC Clinical Category C event (exclusive of cutaneous Kaposi's sarcoma) at screening. Treatment for the acute event must have been completed at least 30 days prior to screening.
* Subject is enrolled in one or more investigational drug protocols, which may impact HIV-1 RNA suppression.
* Subject is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
* Subject is either pregnant or breastfeeding.
* Subject has an ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening.
* Subject suffers from a serious medical condition, such as cirrhosis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.
* Subject has a pre-existing mental, physical, or substance abuse disorder which, in the opinion of the investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.
* Subject has a history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction which may interfere with drug absorption or render the subject unable to take oral medication.
* Subject has any acute laboratory abnormality at screening, which, in the opinion of the investigator, precludes the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality will exclude a subject from study participation.
* Subject has estimated creatinine clearance \<50 mL/min via Cockroft-Gault method.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN).
* Subject has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period.
* Subject requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to Screen, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to Screen. Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.
* Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration.
* Subjects who require treatment with the prohibited medications within 28 days of commencement of investigational product, or an anticipated need during the study.
* Subject has a history of allergy to any of the study drugs or any excipients therein
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

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Phoenix, Arizona, United States

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GSK Investigational Site

Phoenix, Arizona, United States

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GSK Investigational Site

Tucson, Arizona, United States

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Beverly Hills, California, United States

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Fountain Valley, California, United States

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Garden Grove, 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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Newport Beach, California, United States

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Oakland, California, United States

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Oakland, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Glastonbury, Connecticut, 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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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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Key West, Florida, United States

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Miami, Florida, United States

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Plantation, Florida, United States

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Port Saint Lucie, Florida, United States

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Sarasota, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Hillsborough, New Jersey, United States

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Newark, New Jersey, United States

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Somers Point, New Jersey, 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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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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West Reading, 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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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Fort Worth, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Longview, Texas, United States

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GSK Investigational Site

Tyler, Texas, United States

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GSK Investigational Site

Annandale, Virginia, United States

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GSK Investigational Site

Charlottesville, Virginia, United States

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GSK Investigational Site

Hampton, Virginia, United States

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GSK Investigational Site

Lynchburg, Virginia, United States

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GSK Investigational Site

Milwaukee, Wisconsin, United States

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GSK Investigational Site

Ponce, , Puerto Rico

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GSK Investigational Site

San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Smith KY, Patel P, Fine D, Bellos N, Sloan L, Lackey P, Kumar PN, Sutherland-Phillips DH, Vavro C, Yau L, Wannamaker P, Shaefer MS; HEAT Study Team. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009 Jul 31;23(12):1547-56. doi: 10.1097/QAD.0b013e32832cbcc2.

Reference Type DERIVED
PMID: 19542866 (View on PubMed)

Other Identifiers

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EPZ104057

Identifier Type: -

Identifier Source: secondary_id

EPZ104057

Identifier Type: -

Identifier Source: org_study_id

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