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

3. Juni 2010 aktualisiert von: GlaxoSmithKline

A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects

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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

688

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • GSK Investigational Site
      • San Juan, Puerto Rico, 00909-1711
        • GSK Investigational Site
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85006
        • GSK Investigational Site
      • Phoenix, Arizona, Vereinigte Staaten, 85012
        • GSK Investigational Site
      • Tucson, Arizona, Vereinigte Staaten, 85745
        • GSK Investigational Site
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90210
        • GSK Investigational Site
      • Fountain Valley, California, Vereinigte Staaten, 92708
        • GSK Investigational Site
      • Garden Grove, California, Vereinigte Staaten, 92845
        • GSK Investigational Site
      • Long Beach, California, Vereinigte Staaten, 90813
        • GSK Investigational Site
      • Los Angeles, California, Vereinigte Staaten, 90069
        • GSK Investigational Site
      • Newport Beach, California, Vereinigte Staaten, 92663
        • GSK Investigational Site
      • Oakland, California, Vereinigte Staaten, 94609
        • GSK Investigational Site
      • Oakland, California, Vereinigte Staaten, 94602
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80204
        • GSK Investigational Site
      • Denver, Colorado, Vereinigte Staaten, 80220
        • GSK Investigational Site
      • Denver, Colorado, Vereinigte Staaten, 80205
        • GSK Investigational Site
    • Connecticut
      • Glastonbury, Connecticut, Vereinigte Staaten, 06033
        • GSK Investigational Site
      • Norwalk, Connecticut, Vereinigte Staaten, 06851
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20007
        • GSK Investigational Site
      • Washington, District of Columbia, Vereinigte Staaten, 20037
        • GSK Investigational Site
      • Washington, District of Columbia, Vereinigte Staaten, 20009
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, Vereinigte Staaten, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Vereinigte Staaten, 33306
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Vereinigte Staaten, 33308
        • GSK Investigational Site
      • Fort Myers, Florida, Vereinigte Staaten, 33901
        • GSK Investigational Site
      • Key West, Florida, Vereinigte Staaten, 33040
        • GSK Investigational Site
      • Miami, Florida, Vereinigte Staaten, 33136
        • GSK Investigational Site
      • Plantation, Florida, Vereinigte Staaten, 33317
        • GSK Investigational Site
      • Port St. Lucie, Florida, Vereinigte Staaten, 34952
        • GSK Investigational Site
      • Sarasota, Florida, Vereinigte Staaten, 34243
        • GSK Investigational Site
      • Sarasota, Florida, Vereinigte Staaten, 34239
        • GSK Investigational Site
      • Tampa, Florida, Vereinigte Staaten, 33614
        • GSK Investigational Site
      • Tampa, Florida, Vereinigte Staaten, 33602
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • GSK Investigational Site
      • Atlanta, Georgia, Vereinigte Staaten, 30339
        • GSK Investigational Site
      • Atlanta, Georgia, Vereinigte Staaten, 30308/30309
        • GSK Investigational Site
      • Augusta, Georgia, Vereinigte Staaten, 30912
        • GSK Investigational Site
      • Decatur, Georgia, Vereinigte Staaten, 30033
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • GSK Investigational Site
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • GSK Investigational Site
      • Chicago, Illinois, Vereinigte Staaten, 60657
        • GSK Investigational Site
      • Maywood, Illinois, Vereinigte Staaten, 60153
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536
        • GSK Investigational Site
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, Vereinigte Staaten, 63108
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89102
        • GSK Investigational Site
    • New Jersey
      • Hillsborough, New Jersey, Vereinigte Staaten, 08844
        • GSK Investigational Site
      • Newark, New Jersey, Vereinigte Staaten, 07102
        • GSK Investigational Site
      • Somers Point, New Jersey, Vereinigte Staaten, 08244
        • GSK Investigational Site
    • New York
      • New York, New York, Vereinigte Staaten, 10065
        • GSK Investigational Site
      • New York, New York, Vereinigte Staaten, 10011
        • GSK Investigational Site
      • Rochester, New York, Vereinigte Staaten, 14604
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten, 28209
        • GSK Investigational Site
      • Greenville, North Carolina, Vereinigte Staaten, 27834
        • GSK Investigational Site
    • Ohio
      • Toledo, Ohio, Vereinigte Staaten, 43614
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97219
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19140
        • GSK Investigational Site
      • West Reading, Pennsylvania, Vereinigte Staaten, 19611
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, Vereinigte Staaten, 29206
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78751
        • GSK Investigational Site
      • Dallas, Texas, Vereinigte Staaten, 75246
        • GSK Investigational Site
      • Dallas, Texas, Vereinigte Staaten, 75208
        • GSK Investigational Site
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • GSK Investigational Site
      • Harlingen, Texas, Vereinigte Staaten, 78550
        • GSK Investigational Site
      • Houston, Texas, Vereinigte Staaten, 77030
        • GSK Investigational Site
      • Houston, Texas, Vereinigte Staaten, 77027
        • GSK Investigational Site
      • Longview, Texas, Vereinigte Staaten, 75604
        • GSK Investigational Site
      • Tyler, Texas, Vereinigte Staaten, 75708
        • GSK Investigational Site
    • Virginia
      • Annandale, Virginia, Vereinigte Staaten, 22003
        • GSK Investigational Site
      • Charlottesville, Virginia, Vereinigte Staaten, 22908
        • GSK Investigational Site
      • Hampton, Virginia, Vereinigte Staaten, 23666
        • GSK Investigational Site
      • Lynchburg, Virginia, Vereinigte Staaten, 24501
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53226
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ABC/3TC
The intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir.
Arzneimittel: abacavir/lamivudine
The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.
Aktiver Komparator: TDF/FTC
The intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
Arzneimittel: emtricitabine/tenofovir
The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
Zeitfenster: Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).
Week 48

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Zeitfenster: Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Week 48
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Zeitfenster: Week 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Week 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Weeks 48 and 96
Median Change From Baseline in HIV-1 RNA at Week 48 and 96
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.
Weeks 48 and 96
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
Zeitfenster: Weeks 48 and 96
A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.
Weeks 48 and 96
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Zeitfenster: Baseline to Week 96
The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.
Baseline to Week 96
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
Zeitfenster: Baseline and time of virologic failure (up to Week 96)
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Baseline and time of virologic failure (up to Week 96)
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Zeitfenster: Baseline and time of virologic failure (up to Week 96)
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.
Baseline and time of virologic failure (up to Week 96)
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Zeitfenster: Baseline through 96 weeks
The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.
Baseline through 96 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2005

Primärer Abschluss (Tatsächlich)

1. April 2008

Studienabschluss (Tatsächlich)

1. April 2008

Studienanmeldedaten

Zuerst eingereicht

25. Oktober 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Oktober 2005

Zuerst gepostet (Schätzen)

27. Oktober 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

8. Juni 2010

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2010

Zuletzt verifiziert

1. Juni 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EPZ104057

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