Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Time to viral suppression below 50c/ml.
研究概览
简要总结
We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.
详细描述
This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.
All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 70 years of age.
- •Sex: Male or Female.
- •Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load.
- •Naïve to HAART.
- •Viral load >100,000c/ml.
- •CD4<200c/ml.
- •Volunteers must be willing and able to provide written informed consent to participate in the study.
- •Available for at least 48 weeks of follow-up.
排除标准
- •Volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite ART.
- •Volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with patient's ability to comply with protocol requirements.
- •Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)
- •Patients with malabsorption or severe chronic diarrhea for more than 30 days.
- •Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day).
- •Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results.
- •Pregnancy or breastfeeding
- •In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence
- •Patient who is currently receiving an experimental medication.
研究组 & 干预措施
Standard Treatment
Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily
干预措施: Efavirenz, lamivudine, and tenofovir (Drug)
Standard Treatment Plus Enfuvirtide
Efavirenz 600mg once daily, Lamivudine 300mg once daily, Tenofovir 300mg once daily and enfuvirtide 90mg subcutaneously twice a day until the viral load is less than 50copies for 2 consecutive visits or 12 weeks (whichever comes first).
干预措施: Enfuvirtide (Drug)
Standard Treatment Plus Enfuvirtide
Efavirenz 600mg once daily, Lamivudine 300mg once daily, Tenofovir 300mg once daily and enfuvirtide 90mg subcutaneously twice a day until the viral load is less than 50copies for 2 consecutive visits or 12 weeks (whichever comes first).
干预措施: Efavirenz, lamivudine, and tenofovir (Drug)
结局指标
主要结局
Time to viral suppression below 50c/ml.
时间窗: Individual
The study is 48 weeks long and the time to viraL suppression will vary depending on the subject. Or there is the possibility that they do not supress
次要结局
- Less then 2.0 log decrease in viral load at week 8.(Week 8)
- Inability to achieve Viral load <50c/ml by week 12.(Week 12)
- Log viral copy/ml decrease over time during phase 1 and phase 2.(Over the 48 week study period)
- Time to loss of viral response. Loss of viral response defined as:(Over the 48 week study period)
- Development of clinical mutations.(Over the 48 week study period)
- Development of sub-clinical mutations (minority variants)(Over the 48 week study period)
- Viral suppression (below 50c/ml) at 24 and 48 weeks.(At 24 and 48 weeks)
- Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral(Over the 48 week study period)
- suppression <50c/ml has occurred(Over the 48 week study period)
- Rate and quantity of HIV-1 proviral DNA decay.(Over the 48 week study period)
- Safety and tolerability.(Over the 48 week study period)