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Ensayos clínicos

Ensayos clínicos

A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001122, AIEDRP AI-05-003
  • Concluido

Propósito del estudio

To compare the rate and durability of virologic suppression in patients receiving maximally assisted therapy (MAT) versus self-administered therapy (SAT) at 24 weeks, and then at 48 weeks and 72 weeks of follow-up.

Infecciones por el VIH
Fase 2

Detalles del estudio

Novel approaches are needed to improve adherence to combination antiretroviral therapy. Nonadherence can lead to reduced drug levels and inadequate viral suppression, which accelerates drug resistance. Thus nonadherence in the first few months of primary HIV infection can limit therapeutic options for an individual years later. Barriers to optimal treatment adherence in patients with early HIV infection include complex treatment regimens which disrupt daily routines, drug intolerance, and concomitant illness including depression. Directly observed therapy has been successful in improving overall effectiveness of antituberculosis therapy and may be a useful strategy in HIV-infected patients.All patients receive combination antiretroviral therapy with didanosine (ddI), stavudine (d4T), efavirenz (EFV), and nelfinavir (NFV). Patients are randomized to self-administered (SAT) versus observed (MAT) therapy for 24 weeks. Patients randomized to MAT receive one directly observed dose (ddI, d4T, EFV, and NFV) of their antiretroviral regimen by a field worker or nurse at the clinic 5 days per week. As a reminder for the second NFV and d4T dose, MAT patients are provided with an alarm watch programmed to sound at dosing times. The alarm watch also serves as a reminder for weekend doses that will not be directly observed. Patients randomized to SAT receive standard care. All patients are monitored with monthly plasma HIV RNA levels and CD4 and CD8 cell counts. At Week 24, all patients are crossed over to SAT for an additional 48 weeks of follow-up.

Criterios de exclusión

    Patients will not be eligible for this study if they: Have cancer (except for Kaposi's sarcoma) that requires treatment. Have a history of hepatitis or pancreatitis. Have peripheral neuropathy. Have an alcohol abuse problem. Are pregnant or breast-feeding. Are taking certain medications, such as rifabutin, rifampin, interleukin, or chemotherapy.

Centros de estudio/contactos


    UCSD, San Diego, California, 92103, United States


    Univ of Texas Southwestern Med Ctr, Dallas, Texas, 75235, United States

Actualizado: 13 de octubre del 2004

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