Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 16
- 主要终点
- Viral load of HIV-1 at each visit with regard to the baseline visit.
研究概览
简要总结
To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.
详细描述
Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.
The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •HIV-1 infected patients.
- •Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
- •Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
- •Subject able to follow the treatment period.
- •Signature of the informed consent.
- •Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
排除标准
- •Hepatic tests > 5 times above normality.
- •Pregnancy or breastfeeding
- •Presence of opportunistic infections and/or recent tumours (< 6 months).
- •Suspected or documented resistance to any of the investigational drugs.
- •Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- •Subjects with abusive consumption of alcohol or illegal drugs.
- •Patients participating in another clinical trial.
研究组 & 干预措施
A
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
干预措施: efavirenz (Drug)
A
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
干预措施: Abacavir+lamivudine (Drug)
结局指标
主要结局
Viral load of HIV-1 at each visit with regard to the baseline visit.
时间窗: At 12, 24, 36 and 48 weeks
次要结局
- To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.(At 12, 24, 36 and 48 weeks)
- To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 48-week treatment period.(At 12, 24, 36 and 48 weeks)
- To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire).(At 12, 24, 36 and 48 weeks)