EUCTR2008-000881-22-IT进行中（未招募）不适用
A randomized, open-label, study of lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily versus lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily in antiretroviral-naive, HIV-1 infected subjects. - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. At least 18 years of age.
- •2. Naïve to antiretroviral treatment (< 7 days of any antiretroviral treatment therapy > 30 days prior to study drug administration).
- •3. No prior treatment with an HIV-1 integrase inhibitor.
- •4. If the subject has been treated for an active AIDS-defining opportunistic infection within 45 days of planned study drug initiation, but is clinically stable and on stable maintenance therapy, the subject may be eligible for participation in the study, only after the investigator contacts the Abbott Medical Monitor to discuss the issue.
- •5. Does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. For complete information, refer to the most current product label for locally approved prescribing information for lopinavir/ritonavir (Kaletra), co-formulated emtricitabine/tenofovir disoproxil fumarate (Truvada), and raltegravir (Isentressä).
- •6. Will notify the principal investigator of any drugs taken during the study, including over the counter medicines, vitamins, minerals, or herbal remedies.
- •7. Not breast-feeding.
- •8. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
- •9. If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must: - use a non-hormonal method of birth control that is acceptable to both the subject and investigator, and is consistent with the locally approved prescribing information for lopinavir/ritonavir
- •10. All female subjects must have a urine pregnancy test performed at the Screening Visit and on Day ?1/Baseline, and results of both tests must be negative.
- •11. Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- •12. Plasma HIV-1 RNA level of greater than or equal to 1,000 copies/mL at Screening and in the investigator's opinion requires antiretroviral therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of an allergic reaction or significant sensitivity to lopinavir/ritonavir, emtricitabine/tenofovir disoproxil fumarate, or raltegravir. 2. Resistance to lopinavir/ritonavir, tenofovir or emtricitabine based on the HIV-1 drug resistance genotypic test results at the Screening Visit. 3. Ongoing history of recreational drug or alcohol use, or a psychiatric illness that could preclude adherence with the protocol. 4. Significant medical history of concomitant illness or disease that would adversely affect his/her participating in this study. 5. Any investigational drug or investigational vaccine received within 30 days prior to study drug administration. 6. The investigator considers the subject to be an unsuitable candidate for the study. 7. Any of the following abnormal screening results: - Hemoglobin /= 3.0 x Upper Limit of Normal (ULN) - Calculated creatinine clearance < 50 mL/min - Hepatitis B surface antigen HBsAg is positive.
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Open-label, Study of Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Raltegravir 400 mg Twice-Daily in Antiretroviral-Naïve, HIV-1 Infected SubjectsEUCTR2008-000881-22-FRAbbott GmbH & Co. KG200
进行中（未招募）
不适用
A Randomized, Open-label, Study of Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Raltegravir 400 mg Twice-Daily in Antiretroviral-Naïve, HIV-1 Infected SubjectsEstudio aleatorizado y abierto de 400/100 mg de lopinavir/ritonavir en comprimidos dos veces al día + coformulación de emtricitabina/tenofovir disoproxil fumarato, 200/300 mg una vez al día, frente a 400/100 mg de lopinavir/ritonavir en comprimidos dos veces al día + raltegravir, 400 mg dos veces al día, en sujetos infectados por el VIH-1 sin tratamiento antirretroviral previo.Treatment-naïve, HIV-1 infected subjectsSujetos infectados por el VIH-1 sin tratamiento antirretroviral previo.MedDRA version: 9.1Level: LLTClassification code 10020162Term: HIV infection CDC Group IEUCTR2008-000881-22-ESAbbott GmbH & Co. KG200
已完成
3 期
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)Human Immunodeficiency Virus InfectionNCT00711009Abbott206
进行中（未招募）
1 期
Pilot simplification study to Lopinavir/ritonavir 800/200 mg monotherapy regimen once dailyEUCTR2011-005981-39-ESnidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
已完成
2 期
A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected SubjectsHIV InfectionsNCT00075231Abbott150