A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Decline in HIV RNA in plasma Rise in CD4 cell count
研究概览
简要总结
Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.
详细描述
This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body.
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
- •ARV naïve subjects
- •Documented HIV infection
- •Documented TB infection
- •Platelet count 40,000/mm3
- •Hemoglobin ≥8.0 g/dL
- •Absolute neutrophil count (ANC) >500/mm3
- •AST (SGOT), ALT (SGPT), and alkaline phosphatase <3 X ULN
- •Total bilirubin <2.5 x ULN
- •Calculated creatinine clearance ≥60 mL/min
- •For women of reproductive potential, negative urine pregnancy test
排除标准
- •Unable to provide informed consent.
- •History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.
- •Patients on hemodialysis.
- •Tuberculosis meningitis.
- •Women with CD4 > 250 and men with CD4 > 400 due to higher risk of hepatotoxicity related to use of NVP.
- •Positive serology for hepatitis C.
- •Evidence for active hepatitis B including positive serologies for HBsAg, HBeAg, or HBV-DNA. Note: If anti-HBs is positive, patient is eligible for study if liver enzymes are within the parameters indicated in the inclusion criteria
- •Women who are breast-feeding
- •Known allergy/sensitivity to study drug(s) or their formulations
- •Patients with other OIs or intercurrent illness that could affect their ability to take study drugs
研究组 & 干预措施
1
Standard dose nevirapine (200 mg 2x daily) in combination with 2 nucleoside analogs
干预措施: efavirenz or nevirapine (Drug)
2
High dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs
干预措施: efavirenz or nevirapine (Drug)
3
Standard dose efavirenz (600 mg at bedtime) in combination with 2 nucleoside analogs
干预措施: efavirenz or nevirapine (Drug)
4
High dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs
干预措施: efavirenz or nevirapine (Drug)
结局指标
主要结局
Decline in HIV RNA in plasma Rise in CD4 cell count
时间窗: Baseline, and Weeks 8, 20 and 32
These laboratory measures would be used to determine if there was a difference in the ARV failure rate between patients receiving standard dose vs high dose treatment with NNRTIs
次要结局
未报告次要终点