Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection With the Objective to Induce a Strong Specific HIV Immune Response Able to Control Viral Replication Without Highly Active Anti-Retroviral Therapy (HAART)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.
研究概览
简要总结
Pilot study for the treatment of primary HIV infection with the objective to induce a strong specific HIV immune response able to control viral replication without HAART.
详细描述
Pilot and open RCT in 20 patients with primary HIV-1 infection who were randomized to one of these two arms: 1) Control arm (A), Tenofovir +Lamivudine + Lopinavir-ritonavir (Kaletra) at standard doses for 44 weeks (W44); a short treatment interruption (TI) was performed at W36, and HAART was restarted for 8 weeks when plasma HIV-1 RNA viral load (pVL) rebounded>200 copies/mL. At W44 HAART was stopped and patients were followed for 48 additional weeks (W92). 2) Immune-based arm (B), same HAART schedule plus oral cyclosporine A (CsA)(serum levels 250-350 mcg/L) for the first 8 weeks of HAART. During the TI, patients received sc GM-CSF (250 mcg TIW) plus weekly sc pegylated-interferon a2b (Peg-INF)(1.5 mcg/kg/week). During the last 8 weeks of HAART (until W44), patients received daily sc low-dose interleukin-2 (IL-2)(0.75 MU/kg QD). The primary endpoint was pVL <1000copies/mL (<3.0 log10/mL) at 12 (W56) and at 48 (W92) weeks after stopping HAART. Sample size was calculated in order to detect a pVL difference of 1.5log10 copies/mL at 12 (W56) weeks after stopping HAART between the control and the immune-based arms with a power of 80% and a level of significance of0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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-infected patients (age 18 years or over) with primary HIV infection <90 days.
- •Giving written informed consent to participate into the study.
排除标准
- •Patients not accepting to start HAART. Patients wishing start HAART treatment with nevirapine or efavirenz.
- •Pregnant women or planning pregnancy.
- •Intravenous drug user or alcohol abuse.
- •Previous treatment with cyclosporin A, GM-CSF,pegylated-interferon-alpha o interleukine-
- •Renal or liver failure.
- •Any formal contraindication to treatment with the study drugs.
- •Patients with a history of psychiatric disorder, thyroid illness, dislipidemia requiring treatment, cardiovascular disease, arterial hypertension, or diabetes mellitus.
- •In treatment with drugs interacting with study drugs.
- •Acute infection for HTLV-I or EBV.
研究组 & 干预措施
HAART
Patients assigned to this arm will receive standard HAART
干预措施: HAART (Drug)
HAART + Immunotherapy
Patients assigned to this arm will receive HAART plus cyclosporin A during the first two months and after that will receive IFN, GM-CSF and IL-2.
干预措施: HAART + Immunotherapy (Drug)
结局指标
主要结局
Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.
时间窗: W12 y W48
次要结局
- Adherence to treatment(W8, W24, W36, W96)
- CD4, CD8(W8, W24, W36, W96)
- Specific HIV immune responses (CD4 and CTL)(W8, W24, W36, W96)
- Adverse events(W8, W24, W36, W96)
- Proportion of patients PVL (plasma viral load)<40(W8, W24, W36, W96)
研究者
Juan A. Arnaiz
MDPhD
Hospital Clinic of Barcelona