EUCTR2005-001490-95-GB进行中（未招募）1 期
A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 (rIL-2, Aldesleukin) with and without Concomitant Antiretroviral Therapy in Patients with HIV-1 Infection and CD4+ Cell Counts = 300/mm3: Study of Aldesleukin with and without Antiretroviral Therapy (ESPRIT 002: STALWART) - STALWART
ational Institute of Allergy and Infectious Diseases (NIAID)0 个研究点目标入组 480 人开始时间: 2005年11月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Documented HIV-1 infection by any licensed ELISA test and confirmed by a second method (e.g., Western Blot); or any one of the following prior to randomization: detectable HIV p24 antigen, quantifiable plasma HIV RNA, or proviral DNA.
- •2. = 18 years of age (children are not eligible for study participation because data on rIL-2 in pediatric HIV disease is limited, and more data on the effects of rIL-2 in the absence of antiretrovirals should be gathered in adults before exposing pediatric patients to these risks).
- •3. The following clinical laboratories obtained within 45 days before randomization:
- •a. One CD4+ T cell count = 300 cells/mm3 (For participants who are status post-splenectomy, also a CD4+ cell percentage on this occasion = 20%).
- •b. AST or ALT < 5 X the upper limit of normal (ULN) range.
- •c. Total or direct bilirubin = 2 X ULN (Participants with hyperbilirubinemia due to Gilbert’s syndrome may have a serum bilirubin up to 5 X ULN).
- •d. Serum creatinine = 2 mg/dl (177 µmol/L).
- •e. Sodium within normal limits.
- •f. Granulocyte count = 1000/mm3.
- •g. Hemoglobin = 10 gm/dl.
- •h. Platelet count = 50,000 cells/mm3.
- •4. Ability to provide informed consent.
- •5. Ability to obtain HAART regimens consisting of = 1 protease inhibitor and = 2 nucleoside or nucleotide reverse transcriptase inhibitors.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any prior history of rIL-2 use
- •2. Use of any approved or experime.ntal antiretroviral drug (including hydroxyurea) within one year prior to randomization.
- •3. In the judgment of the clinician, any current indication for continuous antiretroviral therapy, or any contraindication to antiretroviral therapy.
- •4. Evidence of virological failure on a protease inhibitor or nonnucleoside reverse transcriptase - based antiretroviral regimen.
- •5. Use of systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 45 days prior to randomization.
- •6. Use of any agent (approved or experimental) with clinically significant immunomodulatory effects within 8 weeks prior to randomization.
- •7. History of any AIDS-defining illness (category C., CDC, 1993) or any of the following conditions: extrapulmonary Pneumocystis carinii disease; multi-dermatomal Herpes zoster (= 10 lesions in a non-contiguous site); American trypanosomiasis (Chagas disease) of the CNS; Penicillium marneffii disease; visceral leishmaniasis; non-Hodgkin’s lymphoma of any cell-type; Hodgkin’s lymphoma; bartonellosis; microsporidiosis (> 1 month’s duration); nocardiosis; invasive aspergillosis; or Rhodococcus equi disease.
- •8. Concurrent malignancy requiring cytotoxic chemotherapy.
- •9. Any CNS abnormality that requires ongoing treatment with antiseizure medication.
- •10. Current or historical autoimmune/inflammatory diseases including:
- •a. Inflammatory bowel disease
- •b. Psoriasis
- •c. Optic neuritis
- •d. Any autoimmune/inflammatory diseases with potentially life-threatening complications
- •11. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, or psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation.
- •12. Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization).
- •13. Breastfeeding.
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