Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- CD4+ percentage (change in HIV-1 seropositive patients)
研究概览
简要总结
In the vast majority of those infected with HIV virus who are untreated, there is deterioration in immune health over a period of months or years inevitably leading to full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if started before a certain degree of progression occurs and has saved millions of lives. The investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.
详细描述
The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating qualities in very low dosage and may offer an alternative to ARV drugs that is effective, non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration. LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due to toxicity of current ARV drugs and need for special medical management young HIV infected children are largely neglected particularly in developing countries; LDN can also be made available in a transdermal cream for infants and children who are HIV infected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected
- •CD4 count over 350 (arm 1/group 1)
- •CD4 count over 200 and on ARV's (arms 2,3/groups 2,3)
- •Age between 18 & 60
- •Males or females
- •Exclusion criteria:
- •HIV-1 seronegative
- •HIV-2 infected
- •CD4 count lower than 200
- •patients under age 18
- •Those refusing to be in study
- •Pregnant or breast-feeding women
- •Patients under immuno-suppressor therapy
- •Those with renal or hepatic dysfunction
- •Malaria or tuberculosis
排除标准
- 未提供
研究组 & 干预措施
Naltrexone Low-dose 3mg capsule
Each person in this arm 1 of the study had never received any ARV drugs and in this study received only one Low-Dose Naltrexone 3mg capsule nightly for 9 months (no placebo).
干预措施: Naltrexone (Drug)
Naltrexone Low Dose + ARVs
In this Arm 3, Patients were on ARV's plus being given Naltrexone Low-Dose (3mg) once daily at bedtime for 9 months.
干预措施: Naltrexone + ARV's (Drug)
ARV's (continued,standard) plus Placebo
In this arm 2, patients were started or continued on their standard ARV drugs plus placebo capsule once daily at bedtime; in the 2nd and 3rd arms patients did not know whether they were taking Low-Dose Naltrexone or a placebo.
干预措施: ARV's + Placebo (Other)
结局指标
主要结局
CD4+ percentage (change in HIV-1 seropositive patients)
时间窗: 9 MONTHS
HIV+ patients with CD4+ count over 350 had their CD4 count/percentage measured at beginning, at 15 days, at 1 month, 3 months, 6 months and 9 months (end).
次要结局
- Clinical assessment of evidence of AIDS or other serious illness(9 MONTHS)