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Ensayos clínicos

Ensayos clínicos

A Study on the Effect of Chemotherapy Combined with Anti-HIV Drugs in HIV-Positive Patients

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000899, ACTG 380
  • Concluido

Propósito del estudio

To assess the safety of highly active antiretroviral therapy (HAART) plus low-dose cytoreductive chemotherapy in HIV-infected persons. To assess the impact of cytoreductive chemotherapy (infusions of cyclophosphamide [CTX]) plus HAART on the number of latently HIV-infected cells in lymphoid and peripheral blood compared to the impact of HAART alone.

Infecciones por el VIH
Fase 1

Detalles del estudio

HAART is a potent suppressor of plasma and lymph node HIV RNA. However, studies suggest that HAART cannot significantly diminish reservoirs of chronically HIV-infected cells. Strategies designed to eradicate all HIV infection should seek to actively target these reservoirs. CTX administration has been shown to eliminate a large number of lymphoid tissue T cells and macrophages, appearing to actively target chronically HIV-infected cells. As lymphoid organs are repopulated following initial depletion with CTX, HAART may protect repopulating cells from becoming HIV-infected, resulting in a net additional removal of the HIV-infected lymphoid reservoir.In Step 1 of this 2-step protocol, all patients receive a HAART regimen of nelfinavir (NFV) plus stavudine (d4T) plus lamivudine (3TC). Patients who achieve an acceptable virologic response, defined as 2 consecutive HIV RNA determinations below 500 copies/ml at least 2 weeks apart between Weeks 4 and 16 of Step 1 [AS PER AMENDMENT 10/30/98: defined as 2 consecutive plasma HIV RNA determinations below 50 copies/ml by the Roche Ultrasensitive assay within a 4-week period between Weeks 4 and 24], are randomized to Arm A or B of Step 2. In Arm A, patients receive NFV plus d4T plus 3TC. In Arm B, patients receive NFV plus d4T plus 3TC plus 3 escalating doses of CTX at 6-week intervals. Patients in both arms are followed for at least 52 weeks following randomization to Step 2. During this time, patients undergo blood tests and lymph node biopsies to measure HIV DNA and RNA levels and to characterize the T cell population. Additionally, patients undergo a chest CT of the thymus before randomization to Step 2 and at Week 52 of Step 2. Cerebrospinal fluid may be obtained at Week 52 to determine the amount of HIV RNA and DNA present. [AS PER AMENDMENT 10/30/98: G-CSF is given after the first dose of CTX, at the discretion of the investigator, and after the second and third doses, for up to 14 days, until the absolute neutrophil count is 10,000 cells/mm3. Also, CTX doses may be modified based on pharmacokinetic study results.]

Criterios de exclusión

    You may not be eligible for this study if you: Have had cancer requiring chemotherapy or radiotherapy or certain nervous system diseases. Are sensitive to E. coli-derived proteins. Have an active AIDS-defining illness. Require certain medications. Are pregnant or breast-feeding.

Centros de estudio/contactos

North Carolina

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

    Duke Univ Med Ctr, Durham, North Carolina, 27710, United States

Actualizado: 13 de octubre del 2004

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