HIV-1 Infection MedDRA version: 7.0 Level: LLT Classification code 10020192
Conditions
Sponsors
Abbott France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/ Independent Ethic 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. 2.Subject is at least 18 years of age. 3.If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one barrier method of birth control. 4.If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative. 5.Subject is not breast-feeding. 6.Subject is naïve to antiretroviral treatment with reverse transcriptase inhibitor or protease inhibitor. 7.Subject has a plasma HIV RNA level 100 cells/mm3 at screening. 9.Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. 10.Subject has a Karnofsky Score greater than or equal to 70. 11.Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would adversely affect his/her participating in this study. 12.Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and metheylergonovine), rifampin, lovastatin, simvastatin, and St. John’s wort. 13.Subject agrees not to take any medication during the study, including over the counter medicine, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator. 14.Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott. 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 with an HIV primo-infection status. 2.Presence of the following mutation: In the protease: one among 32, 47, 48, 50, 82, 84, 90 OR more than 3 mutations from the LPV mutation score 10, 20, 24, 46, 53, 54, 63, 71 In the reverse transcriptase: 215 or 184. 3.Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse. 4.Subject has a history of psychiatric illness. 5.Screening laboratory analyses show any of the following abnormal laboratory results: Hemoglobin = 8.0 g/dL, Absolute neutrophil count = 750 cells/µL, Platelet count = 50,000 per mL, ALT or AST = 3.0 x Upper Limit of Normal (ULN), Creatinine = 1.5 x Upper Limit of Normal (ULN), 6.Subject has received any investigational drug within 30 days prior to study drug administration. 7.For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to compare: In antiretroviral-naïve patients the antiviral activity of a lopinavir/ritonavir (LPV/r)-single drug regimen versus a HAART standard triple regimen of lopinavir/ritonavir in combination with zidovudine (AZT) and lamivudine (3TC).;Secondary Objective: Secondary objectives are to compare between the two arms: 1) CD4 evolution 2) In failing patients: occurrence of mutation in the HIV protease and RT 3) Occurrence of AIDS clinical events 4) Safety of NRTI-sparing versus a PI with 2 NRTIs regimen: clinical and biological tolerance i.e. mitochondrial toxicity, metabolic toxicity, fat redistribution with DEXA scan. 5) Patient’s adherence and QOL;Primary end point(s): Proportions of subjects with virologic response defined as having plasma HIV-1 RNA below 400 copies/mL at Week 24 AND below 50 copies/mL at Week 48 and Week 96. | — |
Countries
Italy, Spain
Outcome results
None listed