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

3 de junio de 2010 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

688

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ABC/3TC
The intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir.
Droga: abacavir/lamivudine
The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.
Comparador activo: TDF/FTC
The intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
Droga: emtricitabine/tenofovir
The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2005

Finalización primaria (Actual)

1 de abril de 2008

Finalización del estudio (Actual)

1 de abril de 2008

Fechas de registro del estudio

Enviado por primera vez

25 de octubre de 2005

Primero enviado que cumplió con los criterios de control de calidad

26 de octubre de 2005

Publicado por primera vez (Estimar)

27 de octubre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de junio de 2010

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2010

Última verificación

1 de junio de 2010

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EPZ104057

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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