NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Treatment failure defined as HIV-RNA > 100 cp/ml
研究概览
简要总结
Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza, Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD
Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal will be submitted
详细描述
This is a pilot study to evaluate the efficacy of a two drug combination for Long term HIV maintenance therapy.
The study is conducted in order to confirm the feasibility of the combination of Nevirapine and lamivudine (3TC) in patients with long term fully suppressive therapy.
Patients (n=10) with a stable (>6 months) Nevirapine based triple therapy and a full viral load suppression for at least 2 years will continue their therapy for 6 months with Nevirapine+3TC.
The primary endpoint is treatment failure defined as an HIV-RNA value >100 cp/ml, confirmed by a second measurement.
Preliminary stopping rules are defined if results indicate futility. Futility is defined as a situation, where the investigators would stop their plan to conduct a multicenter comparative trial. Futility is reached, when the study documents more than 1 failure in the first 5 patients over 24 weeks of observation or more than 2 failures in all 10 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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-pos, 18 years
- •Stable ART, Nevirapine based (plus 2 nukleotide-analogues), at least 6 months
- •Viral load suppression at least 24 months Prior to inclusion (<50cp/ml)
排除标准
- •chronic Hepatitis B necessitating tenofovir therapy
研究组 & 干预措施
nevirapine plus lamivudine
patients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC
干预措施: Nevirapine plus lamivudine (Other)
结局指标
主要结局
Treatment failure defined as HIV-RNA > 100 cp/ml
时间窗: 24 weeks
Patients reaching a viral load measurement \>100cp /ml (confirmed) within the first 24 weeks of therapy with monthly HIV-RNA testing.
次要结局
未报告次要终点
研究者
pietro vernazza
Chief Div. Infectious Diseases
Cantonal Hospital of St. Gallen