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Ensayos clínicos

Ensayos clínicos

A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000939, ACTG A5039
  • Concluido

Propósito del estudio

To obtain preliminary data regarding the rates of maintained viral suppression in subjects randomized to 1 of 3 arms: Arm A: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Arm B: Didanosine plus stavudine plus efavirenz (ddI/d4T/EFV). Arm C: Continued therapy with PI (protease inhibitor)-containing regimen. To compare the frequency of toxicity and treatment intolerance on all three arms. To obtain preliminary data regarding the rate at which viral suppression can be achieved and maintained with re-initiation of the pre-entry regimen following virologic failure in Arm A or B compared to the rate of maintained viral suppression in Arm C.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

Combination antiretroviral therapies using protease inhibitors (PIs) are capable of suppressing plasma HIV RNA to undetectable levels. However, approximately 10% of patients who achieve undetectable viral loads will experience a detectable rise in HIV RNA each year. When HIV replication has been suppressed to very low levels, it may be possible to consolidate antiretroviral therapy into a simpler and potentially less toxic "maintenance" regimen without a PI. Such a regimen would ideally be potent enough to continue to maintain viral suppression but use agents that are better tolerated, more easily salvaged, less expensive, and/or more convenient than PI-containing regimens. Subsequent rises in HIV viremia with non-PI maintenance regimens may respond to resumption of the pre-maintenance PI-containing regimen, extending the use of the potent PI class. Patients are randomized 1:1:1 to treatment with ddI/d4T/HU (Arm A) versus ddI/d4T/EFV (Arm B) versus continuation of the pre-entry PI-containing regimen (Arm C). Viral load is measured at Weeks 1, 2, 4, 8, 12, 16, 20, and 24, then every 8 weeks for up to 3 years. Upon virologic failure (plasma HIV RNA greater than or equal to 200 copies/ml), or drug intolerance, patients on the maintenance regimens (Arms A and B) restart their pre-entry PI-containing regimen. Patients on Arm C are managed according to best medical judgment of their primary care provider in the event of virologic failure.

Criterios de exclusión

    You will not be eligible for this study if you: Have taken ddI, d4T, or HU for more than 2 weeks. Have taken any NNRTI (non-nucleoside reverse transcriptase inhibitor) for more than 7 days. Have ever taken EFV. Have received an HIV vaccine within 30 days prior to study entry. Have an AIDS-related cancer that requires chemotherapy. Have or have had pancreatic disease. Are being treated for a significant illness. Abuse drugs or alcohol. Are pregnant or breast-feeding. Are allergic to any study drugs. Have received certain medications.

Centros de estudio/contactos

California

    Willow Clinic, Menlo Park, California, 94025, United States

    Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California, 951282699, United States

    Stanford Univ Med Ctr, Stanford, California, 943055107, United States

    San Mateo AIDS Program / Stanford Univ, Stanford, California, 943055107, United States

Florida

    Univ of Miami School of Medicine, Miami, Florida, 331361013, United States

Indiana

    Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States

    Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, 46202, United States

    Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, 46202, United States

Massachusetts

    Harvard (Massachusetts Gen Hosp), Boston, Massachusetts, 02114, United States

    Beth Israel Deaconess - West Campus, Boston, Massachusetts, 02215, United States

New York

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

    Cornell Univ Med Ctr, New York, New York, 10021, United States

    Beth Israel Med Ctr, New York, New York, 10003, United States

    Chelsea Ctr, New York, New York, 10021, United States

    Univ of Rochester Medical Center, Rochester, New York, 14642, United States

North Carolina

    Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States

Ohio

    Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States

    Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States

Pennsylvania

    Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania, 19104, United States

Actualizado: 13 de octubre del 2004

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