Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT
研究概览
简要总结
To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant
详细描述
Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic hematopoietic stem cell transplant (HSCT). The primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant. If patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of ART. Failure to maintain ART will be defined as ≥ 24 hours without any anti-retroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. Alternatively, two HIV-1 RNA values > 200 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent may be used to document infection.
- •Patients must be ≥ 18 years of age.
- •Plan to undergo a Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:
- •Plan to undergo a Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:
排除标准
- •Patients with a known history of enfuvirtide resistance will not be eligible for this trial.
研究组 & 干预措施
Enfuvirtide monotherapy
Enfuvirtide 90 mg subcutaneously every 12 hours will be also be administered during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions with conditioning regimens in patients who require ritonavir-boosted PI containing ART regimens.
干预措施: Enfuvirtide (Drug)
结局指标
主要结局
Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT
时间窗: 24 hours
Failure to maintain anti retroviral therapy for 24 hours
次要结局
- Number of copies of HIV-1 DNA in blood mononuclear cells at baseline(Baseline)
- Number of copies of HIV-1 DNA in blood mononuclear cells at 12 weeks(12 weeks post-intervention)
- Number of copies of HIV-1 DNA in blood mononuclear cells at 52 weeks(52 weeks post-intervention)
- Number of copies of HIV-1 DNA in blood mononuclear cells at 2 years(2 years post-intervention)
- Number of copies of HIV-1 DNA in blood mononuclear cells at 24 weeks(24 weeks post-intervention)
- Number of copies of HIV-1 DNA in blood mononuclear cells at 36 weeks(36 weeks post-intervention)