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Comparación de dos formas de administrar el tratamiento contra el VIH (Estudio SMART)

Concluido
Patrocinador(es) del estudio
National Institute of Allergy and Infectious Diseases (NIAID)

Números de identificación
NCT00027352, CPCRA 065

Propósito del estudio

Propósito del estudio

El propósito de este estudio es comparar dos formas de usar medicamentos antirretrovirales para así ayudar a los proveedores de la salud y los pacientes a determinar cómo usar mejor a través de los años los tratamientos contra el VIH. Muchos proveedores de la salud tratan ahora a los pacientes con medicamentos diariamente para mantener la concentración del VIH en la sangre (carga viral) lo más baja posible. Este método ayuda a aquellos pacientes cuyo recuento de células CD4 está por debajo de 200 a 250 células/mm3 a vivir más tiempo sin padecer de enfermedades graves. Aún no se sabe si esta es la mejor forma de tratar a pacientes con un recuento más alto de células CD4. Existe información que sugiere que los pacientes infectados por el VIH pueden esperar para usar medicamentos contra este virus mientras que sus recuentos de células CD4 sean superiores a 250 células/mm3. Como este estudio se llevará a cabo por vario años, proveerá información sobre las ventajas y desventajas a largo plazo de estas dos estrategias de tratamiento.

Afección:
Infecciones por el VIH

Detalles del estudio

Detalles del estudio

La implementación de las pautas del tratamiento antirretroviral (ART), que hace énfasis en la supresión máxima y duradera de la carga viral para la mayoría de las personas infectadas por el VIH, ha dado como resultado una disminución considerable en las tasas de morbilidad y mortalidad. Sin embargo, muchos pacientes asintomáticos no corren un riesgo inmediato de enfermedades oportunistas graves, la eficacia del tratamiento antirretroviral disminuye con el tiempo debido a la resistencia al medicamento contra el VIH y hay toxicidad del tratamiento a corto y largo plazo. Esto motiva a la comparación de dos estrategias: Una que mantiene los tratamientos difiriendo su uso mientras que el riesgo de enfermedad oportunista es bajo y otra cuya finalidad es la supresión virológica continua, independientemente del riesgo de enfermedad. En este ensayo grande, a largo plazo, los pacientes serán asignados al azar ya sea al grupo de conservación del medicamento (DC) o al grupo de supresión viral (VS). Los pacientes se inscribirán durante un periodo de 3 años y se les hará seguimiento por un promedio de 7.5 años. El grupo DC suprimirá o pospondrá el tratamiento antirretroviral (ART) hasta que el recuento de células CD4 llegue a por debajo de 250 células/mm3, en ese momento recibirán tratamiento para aumentar el recuento de CD4 a por encima de 350 células/mm3, seguido de tratamiento antirretroviral episódico basado en el recuento de células CD4. El grupo VS usará el tratamiento antirretroviral para mantener la carga viral tan baja como sea posible, independientemente del recuento de células CD4. Los pacientes asistirán a consulta médica en los meses 1, 2, 4, 6, 8, 10 y 12 y luego cada cuatro meses para visitas de recolección de datos. Todos los tratamientos antirretrovirales estarán disponibles, incluso los inmunomoduladores y las pruebas de resistencia pueden usarse para los pacientes en los dos grupos de tratamiento. A ciertas submuestras de pacientes inscritos en el estudio se les hará seguimiento con una recolección de datos más intensa para ver el resultado secundario relacionado al costo y utilización de la atención médica, calidad de vida, riesgos de comportamiento para la transmisión del VIH y complicaciones metabólicas del tratamiento.


Criterios de inclusión

Criterios de inclusión

    Los pacientes podrán participar en el estudio si:
    • Han comprobado que tienen infección por el VIH.
    • Tienen un recuento de células CD4 superior a 350 células/mm3 durante los 45 días anteriores al ingreso al estudio.
    • Están dispuestos a empezar, cambiar o suspender el tratamiento antirretroviral.
    • Se comprometen a usar métodos eficaces de control de la natalidad.
    • Tienen buena salud al momento del ingreso al estudio.
    • Están disponibles para participar en el estudio por lo menos por 6 meses.
    • Pueden, según la opinión del investigador, cumplir con el protocolo.

Criterios de exclusión

  • Los pacientes no podrán participar en el estudio si:
    • Actualmente participan en el estudio CPCRA FIRST, MDR-HIV o NvR u otro estudio que no es coherente con uno de los grupos de tratamiento en este estudio.
    • Están embarazadas o dando de pecho.
Contact information

Centros de estudio/contactos

California

Kaiser Permanente-Fremont/Hayward Medical Centers, Fremont, California, 94538, United States

AIDS Healthcare Foundation, Los Angeles, California, 90015, United States

Los Angeles Gay and Lesbian Community Service Ctr, Los Angeles, California, 90028, United States

Community Consortium / UCSF, San Francisco, California, 94110, United States

Dr. Shawn Hassler, San Francisco, California, 94110, United States

East Bay AIDS Ctr, San Francisco, California, 94110, United States

Lawrence Goldyn, MD, San Francisco, California, 94110, United States

Colorado

Drs. Lichtenstein & Greenberg, Denver, Colorado, 80204-4507, United States

Western Infectious Disease Consultants, Denver, Colorado, 80204-4507, United States

Denver CPCRA / Denver Public Hlth, Denver, Colorado, 802044507, United States

McDowell Healthcare Center, Denver, Colorado, 80204, United States

Connecticut

Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit, New Haven, Connecticut, 065102483, United States

Veterans Administration Medical Center, New Haven, Connecticut, 06510, United States

Delaware

Christiana Care Health Services HIV Program George, Wilmington, Delaware, 19801, United States

District of Columbia

Timothy A Price, Washington, District of Columbia, 204220001, United States

George Washington Univ, Washington, District of Columbia, 20422, United States

Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia, 20422, United States

Florida

Miami Veterans Affairs Med Ctr, Miami, Florida, 33125, United States

Center for Prevention and Treatment of Infections, Pensacola, Florida, 32504, United States

Treasure Coast Infectious Disease Consultants, Vero Beach, Florida, 32960, United States

Georgia

Absolute Care Clinic, Atlanta, Georgia, 30308, United States

AID Atlanta/Morehouse Med School Ryan White Cl, Atlanta, Georgia, 30308, United States

AIDS Research Consortium of Atlanta (ARCA) Central, Atlanta, Georgia, 30308, United States

Cobb-Douglas County Infectious Disease Clinic, Atlanta, Georgia, 30308, United States

Dekalb County Health Dept Infectious Disease, Atlanta, Georgia, 30308, United States

Dr. Dennis Melton (Private Practice), Atlanta, Georgia, 30308, United States

Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice), Atlanta, Georgia, 30308, United States

Dr. Richard Hudson (Private Practice), Atlanta, Georgia, 30308, United States

Idaho

HIV Services Clinic/Family Practice Medical Center, Boise, Idaho, 83704, United States

Illinois

Cook County Hosp, Chicago, Illinois, 606576156, United States

Klein and Slotten Associates / AIDS Research Alliance, Chicago, Illinois, 606576156, United States

Lakeshore Infectious Disease Associates, Chicago, Illinois, 606576156, United States

University of Illinois at Chicago, Chicago, Illinois, 606576156, United States

AIDS Research Alliance - Chicago, Chicago, Illinois, 60657, United States

Northside Family Medicine, Chicago, Illinois, 60657, United States

Northwestern Memorial Physicians, Chicago, Illinois, 60657, United States

University of Chicago, Chicago, Illinois, 60657, United States

Southern Illinois University (SIU) School of Medicine, Springfield, Illinois, 62702, United States

Kansas

KU Medical School-Wichita, Midtown Clinic, Wichita, Kansas, 37214-3199, United States

KU Medical School-Wichita, MPA, Wichita, Kansas, 37214-3199, United States

Louisiana

University of Mississippi Medical Center, New Orleans, Louisiana, 70112-2699, United States

Our Lady of the Lake Regional Med Ctr, New Orleans, Louisiana, 701122699, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, 70112, United States

Massachusetts

Community Research Initiatives of New England, Boston, Massachusetts, 02215, United States

Community Research Initiatives/ProACT, Boston, Massachusetts, 02215, United States

Community Research Initiative/ProACT, Springfield, Massachusetts, 01107, United States

Michigan

University of Michigan Health System, Ann Arbor, Michigan, 48100-0378, United States

Detroit Community Health Connection, Detroit, Michigan, 48201, United States

Detroit Receiving, Detroit, Michigan, 48201, United States

Wayne State Univ / Medical College of Ohio at Toledo, Detroit, Michigan, 48201, United States

Henry Ford Hosp, Detroit, Michigan, 48202, United States

Mt. Clemens General Hospital, Detroit, Michigan, 48202, United States

Providence Hosp- Newland Med Assoc. Inc., Detroit, Michigan, 48202, United States

McAuley Health Center, Grand Rapids, Michigan, 49503, United States

Michigan State University Infectious Diseases Clinic, Lansing, Michigan, 48910, United States

William Beaumont Hospital/CORNET, Royal Oak, Michigan, 48073, United States

Minnesota

Mayo Clinic/CORNET, Rochester, Minnesota, 55905, United States

New Jersey

Cooper Hospital Early Intervention Program, Camden, New Jersey, 08103, United States

Jersey Shore Med Ctr, Neptune, New Jersey, 07753, United States

Raritan Bay Med Ctr, Newark, New Jersey, 071032842, United States

Saint Michael's Med Ctr, Newark, New Jersey, 071032842, United States

Jeffrey Bomser Clinic / NJCR, Newark, New Jersey, 07103, United States

New Jersey Community Research Initiative, Newark, New Jersey, 07103, United States

NJCRI, Newark, New Jersey, 07103, United States

South Jersey Infectious Disease, Somers Poinnt, New Jersey, 08244, United States

New York

Bronx-Lebanon Hosp Ctr, Bronx, New York, 10453, United States

Bronx Veterans Affairs Medical Center, Bronx, New York, 10468, United States

SUNY Downstate Med Ctr, Brooklyn, New York, 11023, United States

Grant Houses Health Ctr, New York, New York, 10037, United States

HHC MMC Unit #1, New York, New York, 10037, United States

HHC Outpatient Clinics, New York, New York, 10037, United States

Jacobi Medical Center, New York, New York, 10037, United States

Lenox Avenue Health Ctr, New York, New York, 10037, United States

Lincoln Medical & Mental Health Center, New York, New York, 10037, United States

Polo Grounds Health Care Ctr, New York, New York, 10037, United States

Syndenham Neighborhood Family Care Ctr, New York, New York, 10037, United States

Metropolitan Hospital Center, New York, New York, 10039, United States

North Carolina

Wake Forest Univ Health Sciences, Winston-Salem, North Carolina, 27157-1042, United States

Oklahoma

Univ of Oklahoma Health Sciences, Oklahoma City, Oklahoma, 73104, United States

Oregon

Legacy Clinic NE, Portland, Oregon, 97209-2534, United States

Salem Hospital, Portland, Oregon, 97209-2534, United States

The Research & Education Group / Multomah Cnty Hlth Dept, Portland, Oregon, 972105311, United States

The Research & Education Group / The R & E Grp Office, Portland, Oregon, 972105311, United States

The Research & Education Grp / Oregon Hlth Sci Univ, Portland, Oregon, 972105311, United States

The Rsch & Ed Grp / Legacy Cln at Good Samaritan, Portland, Oregon, 972105311, United States

The Rsch & Ed Grp / Providence Portland Med Ctr, Portland, Oregon, 972105311, United States

The Research and Education Group, Portland, Oregon, 97210, United States

Pennsylvania

Penn Community Infectious Diseases, Philadelphia, Pennsylvania, 19107, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States

Einstein Medical Center, Philadelphia, Pennsylvania, 19140, United States

Temple Univ School of Medicine, Philadelphia, Pennsylvania, 19140, United States

Texas

Montrose Clinic, Houston, Texas, 77006, United States

Houston Veterans Administration Med Ctr, Houston, Texas, 77030, United States

Univ TX Health Science Ctr, Houston, Texas, 77030, United States

University Clinical Research Center, Houston, Texas, 77030, United States

South Texas Veterans Health Care System, San Antonio, Texas, 78229, United States

Virginia

Infectious Disease Associates of Virginia, Lynchburg, Virginia, 24501, United States

Cross Over Clinic / Div of Infectious Diseases, Richmond, Virginia, 232980049, United States

McGuire VA / Division of Infectious Diseases, Richmond, Virginia, 232980049, United States

MCV ID Clinic, Richmond, Virginia, 23298, United States

MediCorp, Infectious Disease Associates, Richmond, Virginia, 23298, United States

Petersburg Health Care Alliance, Richmond, Virginia, 23298, United States

South Richmond Health Ctr, Richmond, Virginia, 23298, United States

Vernon J. Harris East End Community Health Care Ct, Richmond, Virginia, 23298, United States

Wisconsin

University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program, Madison, Wisconsin, 53792, United States

Hospital de Clinicas Jose de San Martin, Buenos Aires, Wisconsin, 53792, Argentina

Hospital de Infecciosas F.J. Muniz, Buenos Aires, Wisconsin, 53792, Argentina

Hospital Gn'l de Agudos JM Ramos Mejia, Buenos Aires, Wisconsin, 53792, Argentina

Hospital Gn'l de Agudos T. Alvarez, Buenos Aires, Wisconsin, 53792, Argentina

Hospital Italiano de Buenos Aires, Buenos Aires, Wisconsin, 53792, Argentina

Hospital Rawson, Cordoba, Wisconsin, 53792, Argentina

Hospital Interzonall de San Juan de Dios, La Plata, Wisconsin, 53792, Argentina

Hospital Central, Mendoza, Wisconsin, 53792, Argentina

CAICI, Rosario, Wisconsin, 53792, Argentina

South Australia

Royal Adelaide Hospital, Adelaide, South Australia, 53792, Australia

Victoria

Prahran Market Clinic, South Yarra, Victoria, 53792, Australia

The Centre Clinic, South Yarra, Victoria, 53792, Australia

Burwood Street General Pratice, Burwood Nsw, Victoria, 2134, Australia

Royal Perth Hosp, Perth, Victoria, 2134, Australia

Alfred Hosp, Prahan, Victoria, 2134, Australia

Royal Prince Alfred Hospital, Prahan, Victoria, 2134, Australia

National Centre in HIV Epidemiology and Clinical Research, Sydney, Victoria, 2134, Australia

University of Vienna Medical School, AKH, Vienna, Victoria, A-1090, Austria

Institute of Tropical Medicine, Antwerp, Victoria, 2000, Belgium

Centre Hospitalier Universitaire Sart-Tilman, Liege, Victoria, 4000, Belgium

RJ

Hospital Escola Sao Francisco de Asis, Rio de Janeiro, RJ, 20210.030, Brazil

RS

Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, 91350-200, Brazil

S.p. Cep

Instituto de Infectologia Emilio Ribas, Sao Paulo, S.p. Cep, 01246, Brazil

Cassiano Antonio de Moraes University Hospital, Boqueirao-Santos, S.p. Cep, 11045-904, Brazil

Centro de Pesquisa Clinical do Hospital Guilherme, Boqueirao-Santos, S.p. Cep, 11045-904, Brazil

Hospital de Clinicas de Porto Alegre, Porto Alegre-RS Cep, S.p. Cep, 90035, Brazil

Hospital dos Servidores do Estado, Rio de Janeiro, S.p. Cep, 20221-903, Brazil

Hospital Universitario Professor Edgard Santos, Salvador-BA, S.p. Cep, 110-160, Brazil

Centro de Referencia e Treinamento DST/AIDS, San Paulo, S.p. Cep, 04121-000, Brazil

Unidade de Pesquisa Clinica, San Paulo, S.p. Cep, 13083-970, Brazil

Ambulatorio de Imunodeficiencias Secundarias/Der30, Sao Paulo, S.p. Cep, 01246-900, Brazil

Universidade Federal De Sao Paulo-Hospital Sao Paulo, Sao Paulo, S.p. Cep, 04040-002, Brazil

British Columbia

Downtown Infectious Disease Clinic, Vancouver, British Columbia, V6Z 2C7, Canada

Nova Scotia

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, NS B3H 1V7, Canada

Ontario

Hamilton Health Science Centre-McMaster, Hamilton, Ontario, L8N 3Z5, Canada

St. Joseph's Health Care Centre of London, London, Ontario, N5Y 3H6, Canada

St. Josephs Hospital, London, Ontario, N5Y 3H6, Canada

The HAVEN Program, HRSRH, Sudbury, Ontario, P3E 5J1, Canada

Tronto General Hospital, Toronto, Ontario, M5G 2N2, Canada

HIV Care Program, Windsor Regional Hospital, Windsor, Ontario, N8W 1E3, Canada

Quebec

University de Sherbrooke, Fleurimont, Quebec, JIH 5N4, Canada

Clinique Medicale L'actuel, Montreal, Quebec, H2L 4P9, Canada

Montreal Chest Institute/Royal Victoria Hospital, Montreal, Quebec, H2X 2P4, Canada

Centre hospitalier de l'universite Laval (CHUL), Sainte-Foy, Quebec, F1V 4G2, Canada

Recherche Clinique Centre Medical Halles de Saint-, Ste-Foy, Quebec, G1V 4P9, Canada

West-Tallinn Central Hospital, Tallinn, Quebec, 10617, Estonia

CHU de la Region Annecienne, Annecy, Quebec, 74011, France

Hopital Pellegrin, Bordeaux, Quebec, 33076, France

Centre Hospitalier Universitaire, Chu-grenoble, Quebec, 33076, France

Hopital Louis Mourier, Colombes, Quebec, 33076, France

Hopital Sainte-Marguerite, Marseille, Quebec, 13009, France

Hopital Saint-Louis, Paris, Quebec, 75010, France

Hopital Pitie Salpetriere, Paris, Quebec, 75651, France

Klinik fur Dermatologie, Venerologie, Allergologie, Essen, Quebec, 45122, Germany

Johann Wolfgang Goethe University Hospital, Frankfort, Quebec, 60590, Germany

Klinikum der Ruprecht-Karis-Universitat (U. Hospital), Heidelberg, Quebec, D-69115, Germany

University Hospital Zurich, Zurich Ch-, Quebec, 8091, Germany

St. James Hospital, Dublin 8, Quebec, 8091, Ireland

Ramathibodi Hospital, Tel Aviv, Quebec, 64239, Israel

U.O. Malattie Infettive, H.S.Maria Annunziata, Antella-Firenze, Quebec, 50011, Italy

SOCDU Malattie Infettive Ospedale Civile Asti, Asti, Quebec, 14100, Italy

Instituto de Malattie Infettive e Tropicali, Brescia, Quebec, I-25125, Italy

Malattie Infettive Busto, Busto Arsizio (va), Quebec, 21052, Italy

Universita degli Studi di Modena e Reggio Emilia, Modena, Quebec, 41100, Italy

Clinica Malattie Infettive, Pavia, Quebec, 27100, Italy

I.R.C.C.S."L.Spallanzani", Rome, Quebec, 00149, Italy

University of Turin, Torino, Quebec, 10149, Italy

Servizio Regionale di Immunologia Clinica e Tipizz, Torrette Di Ancona, Quebec, 71-60020, Italy

S.S. Giovanni e Paolo Hospital, Venice, Quebec, 71-60020, Italy

AIDS Medical Center, International Medical Center, Tokyo, Quebec, 162-8655, Japan

International Medical Center of Japan, Tokyo, Quebec, 162-8655, Japan

Lithuanian AIDS center, Vilnius, Quebec, 03011, Lithuania

Centre Hospitalier de Luxembourg, Barble, Quebec, L-1210, Luxembourg

C.H.U. Fort-de-France, Fort-de-france, Quebec, 97261, Martinique

Christchurch Hosp, Christchurch, Quebec, 97261, New Zealand

Wellington Hosp, Wellington, Quebec, 97261, New Zealand

Ulleval Hospital, Oslo, Quebec, N-0407, Norway

Hospital Nacional Edgardo Rebagliati Martins, Lima, Quebec, 11, Peru

Hospital Nacional Guillermo Almenara Irigoyen, Lima, Quebec, 13, Peru

Wroclaw University School of Medicine, Koszarowa Str. 5, Quebec, 13, Poland

Instituto A. Z. de Pesquisa e Ensino, Curitiba, Quebec, 80430-040, Puerto Rico

Hospital de la Santa Creu i Sant Pau, Barcelona, Quebec, E08025, Spain

Hospital Universitario de La Princesa, Madrid, Quebec, E-28006, Spain

Hospital Universitario Principe de Asturias, Madrid, Quebec, E-28805, Spain

Hospital U. Virgen del Rocio, Sevilla, Quebec, 41013, Spain

Hospital Mutua de Terrassa, Terrassa, Quebec, 08221, Spain

Consorcio Hospital General Universitario de Valencia, Valencia, Quebec, 46014, Spain

University Hospital Basel, Basel Ch, Quebec, 4031, Switzerland

Poliklinik fur Infektiologie, Bern, Quebec, 3010, Switzerland

Hopital de la Ville, La Chaux-de-Fonds, Quebec, 2300, Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Quebec, 1011, Switzerland

Ospedale Regionale di Lugano, Lugano, Quebec, 6903, Switzerland

Sanpatong Hospital, Chiang Mai, Quebec, 50120, Thailand

Bamrasnaradura Institute, Nonthaburi 11000, Quebec, 50120, Thailand

England

John Radcliffe Hospital, Oxford, England, OX3 9DU, United Kingdom

Royal Victoria Hospital, Belfast, England, BT12 6BA, United Kingdom

Hawthorn House, Birmingham Heartlands NHS Trust, Birmingham, England, B9 5SS, United Kingdom

Southmead Hospital, Bristol, England, BS10 5NB, United Kingdom

St. Helier Hospital, Carshalton, Surrey, England, SM5, 1AA, United Kingdom

St. Helier Hospital, Carshalton, England, SM5, 1AA, United Kingdom

Essex County Hospital, Essex, England, CO3 3NB, United Kingdom

Victoria General Hospital, Q.E. II Health Sciences, Halifax, England, CO3 3NB, United Kingdom

Homerton University Hospital NHS Foundation Trust, London, England, E9 6SR, United Kingdom

Barts and The London, NHS Trust, London, England, EC1A 7BE, United Kingdom

Central Middlesex Hospital, London, England, NW10 7NS, United Kingdom

Royal Free Hospital, London, England, NW3 2QG, United Kingdom

St. Thomas' Hospital, London, England, SE1 7EH, United Kingdom

T1 Coleridge Unit, North Middlesex Hospital, London, England, SE5 9RS, United Kingdom

The Caldecot Centre, Kings College Hospital NHS Tr, London, England, SE5 9RS, United Kingdom

Chelsea and Westminster Hospital, London, England, SW10 9NH, United Kingdom

St. George's Hospital, London, England, SW17 ORE, United Kingdom

St. Mary's Hospital, London, England, W1 2NY, United Kingdom

The Mortimer Market Center, London, England, WC1E 6AU, United Kingdom

The James Cook University Hospital, Middlesbrough, England, TS4 3BW, United Kingdom

Pasteur Suite, Ealing Hospital, Middlesex, England, UB1 3HW, United Kingdom

Newcastle General Hospital, Newcastle, England, NE4 6BE, United Kingdom

Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital, Sheffield, England, S10 2JF, United Kingdom

Watford Sexual Health Center;Watford General Hosp, Watford Wd, England, 18 0HB, United Kingdom

Actualizado: 12 de noviembre del 2004