A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered with Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral experienced, HIV-1 Infected Subjects
- Conditions
- Antiretroviral experienced, HIV-1 Infection. Adequate ICD classification code not available.MedDRA version: 14.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2006-000748-14-GB
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
A subject will be eligible for study participation if he/she meets the following criteria: 1. Subject is at least 18 years of age. 2. Subject has 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. 3. Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the knowledge of the principal investigator. 4. Subject does not require and agrees not to take any drugs that are contraindicated 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®) and other investigator-selected coadministered antiretroviral agents. 5. Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug (as denoted by * in Appendix D). Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Abbott Medical Monitor. 6. Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. 7. If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oorphorectomy 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; and have a urine pregnancy test performed at the Screening Visit and on Day 1/Baseline, and results of both tests must be negative. 8. Subject is not breast-feeding. 9. Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 weeks. 10. Subject has never received lopinavir/ritonavir. 11. Subject is currently failing his/her antiretroviral regimen with the most recent two consecutive pre-study plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy. 12. Subject has plasma HIV-1 RNA levels > 1000 copies/mL at Screening. 13. Based on HIV-1 drug resistance genotypic test results at the Screening Visit and prior treatment history, the investigator considers lopinavir/ritonavir plus at least two NRTIs to be an appropriate treatment for the subject. 14. Subject does not require and agrees not to take any antiretroviral medication except lopinavir/ritonavir and NRTIs.
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
A subject will be excluded from the study if he/she meets any of the following criteria: 1. Subject has a history of an allergic reaction or significant sensitivity to lopinavir or ritonavir. 2. Subject has an ongoing history of substance abuse (recreational drugs, alcohol) or psychiatric illness that could preclude adherence with the protocol. 3. Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic or hepatic disease that would adversely affect his/her participating in this study. 4. Subject has received any investigational drug or investigational vaccine within 30 days prior to study drug administration. 5. For any reason, subject is considered by the investigator to be an unsuitable candidate for the study. 6. Screening laboratory analyses show any of the following abnormal laboratory results: ? Hemoglobin less than or equal to 8.0 g/dL ? Absolute neutrophil count less than or equal to 750 cells/mL ? Platelet count less than or equal to 50,000 mm3 ? ALT (SGPT) or AST (SGOT) greater than or equal to 5.0 x Upper Limit of Normal (ULN) 7. Medications such as phenolbarbital, phenytoin and carbamazepine may decrease the effectiveness of Kaletra (lopinavir/ritonavir). These medications should not be used with once-daily dosing of Kaletra (lopinavir/ritonavir).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this study are to compare the safety, tolerability and antiviral activity of QD and BID dosing of the lopinavir/ritonavir tablet formulation in subjects with detectable viral load while receiving their current antiretroviral therapy.;Secondary Objective: The secondary objective of this study is to characterize the development of resistance in QD and BID dosing of the lopinavir/ritonavir tablet in antiretroviral-experienced subjects.;Primary end point(s): The primary efficacy variable will be the proportion of subjects responding (i.e., not demonstrating virologic failure) at Week 48.
- Secondary Outcome Measures
Name Time Method