A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients.
研究概览
简要总结
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
详细描述
This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.
Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients >18 years of age with documented HIV-1 infection
- •Naïve to antiretroviral therapy
- •Able and willing to provide written informed consent
- •No CD4 restriction
- •HIV-1 RNA levels >5000 c/mL
- •Female patients must meet these additional criteria
- •Non-childbearing potential
- •Negative serum pregnancy test at screen
- •Willingness to abstain from sexual intercourse or use double barrier contraception
排除标准
- •Presence of any of the following:
- •Aminotransferases >3xULN
- •Hemoglobin concentration <8.0g/dl
- •Absolute neutrophil count <800 cells/cubic mm
- •Platelet count <50,000 cells/cubic mm
- •Acute illness, or an acute illness ≤7 days
- •Presence of Opportunistic Infection, or an OI within 30 days of screening
- •Acute or chronic active Hepatitis B
- •Hepatitis C
- •Creatinine Clearance <50 mL/min
- •Pregnant or breast-feeding women
- •Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
- •Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
- •Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
- •Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.
研究组 & 干预措施
Once daily
Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours.
干预措施: Once daily (Drug)
结局指标
主要结局
To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients.
时间窗: 4, 8, 12, 16, 24, 32, 40, and 48 weeks
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to \<50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
次要结局
- Proportion of Patients With <400copies/ml(4,8, and 12 weeks)
- Review Virologic Response to Assess Rate of Viral Decline.(weeks 4, 8, 12, 16, and 24)
- Proportion of Patients With <50 Copies/ml HIV-1 RNA(at weeks 4, 8, 12, 16, 24, 32, 40, and 48)
- Change From Baseline CD4 Counts(at weeks 4, 8, 12, 16, 24, 32, 40, and 48)
- Time to Virologic Failure.(Week 48)
- Tolerability and Adverse Events.(48 weeks)
- Change From Baseline Fasting Total Cholesterol and Fasting Triglyceride Levels.(48 weeks)
- Characterize Adherence Rates for This Therapeutic Regimen by the Use of Medication Electronic Monitoring Systems (MEMS) Caps.(48 weeks)
- Characterize Adherence Rates for This Therapeutic Regimen by Use of Pharmacy Refill Records.(48 weeks)
- Assess Genotypic Changes in Patients With Virologic Failure.(48 weeks)
- Assess Lopinavir Trough Levels in Patients Failing to Obtain Virologic Suppression.(48 weeks)
研究者
Johnny Stephens
Associate Professor
Oklahoma State University Center for Health Sciences