HIV-1 infection
Conditions
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Criteria for Inclusion: Adult male or female subjects of atleast 18 years of age, who have provided written informed consent. Plasma HIV-1 RNA > or = 1000 copies/mL at screening, and in the Investigator's opinion requires antiretroviral therapy.Subject is naive to antiretroviral treatment( 30 days prior to study drug administration). Subject has not been treated for an active AIDS-defining opportunistic infection within 45 days of initiating study drug.Subjects who are on stable maintenance therapy for opportunistic infection may be enrolled after consultation with Abbott.Subjects who do not require and agree not to take any drugs that are contraindicated or have a significant pharmacokinetic interaction with study drugs during the course of the study.Subjects who agree not to take any medication including over-the-counter, vitamins, minerals, herbal products etc without the permission of the principal investigator.Non-breast-feeding subjects.Female subjects of non-chlid-bearing potential(post-menopausal for atleast 1 year or surgically sterile), or females of child-bearing potential practising one of the contraceptive methods stated in the protocol. Females who have a negative pregnancy test performed at screening and Day 1. Subjects whose vital signs do not show indication of acute illness. 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
Exclusion criteria
Exclusion criteria: 1. Subject has a history of an allergic reaction or significant sensitivity to lopinavir/ritonavir, tenofovir disoproxil fumarate, emtricitabine, lamivudine 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 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: ? Presence of hepatitis B surface antigen (HBsAg) ? Hemoglobin = 8.0 g/dL ? Absolute neutrophil count = 750 cells/µL ? Platelet count = 50,000 per mL ? ALT (SGOT) or AST (SGPT) = 3.0 x Upper Limit of Normal (ULN) ? Calculated creatinine clearance < 50 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: ? To compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir tablet formulation with the marketed SGC formulation. ? To compare the safety, tolerability and antiviral activity of QD and BID dosing of the lopinavir/ritonavir tablet formulation.;Secondary Objective: The secondary objectives of this study are: ? To characterize the development of resistance in QD and BID dosing of the lopinavir/ritonavir tablet. ? To characterize the pharmacokinetics of the lopinavir/ritonavir tablet in HIV-1 infected subjects following multiple dose administration.;Primary end point(s): | — |
Countries
Czech Republic, Germany, Greece, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed