Treatment-naïve, HIV-1 infected subjects MedDRA version: 9.1 Level: LLT Classification code 10020162 Term: HIV infection CDC Group I
Conditions
Interventions
Trade Name: Kaletra 200 mg/50 mg film-coated tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: lopinavir
Current Sponsor code: ABT-378
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age. 2. Naïve to antiretroviral treatment ( 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 (as denoted by * in Appendix D) 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 (Isentress™). 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. ? 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. 10. Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. 11. 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
Exclusion criteria
Exclusion criteria: 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 = 8.0 g/dL ? Absolute neutrophil count = 750 cells/µL ? Platelet count = 50,000 per mL ? ALT (SGPT) or AST (SGOT) = 3.0 × Upper Limit of Normal (ULN) ? Calculated creatinine clearance < 50 mL/min ? Hepatitis B surface antigen HBsAg is positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To compare the safety and tolerability of lopinavir-ritonavir (LPV/r) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) with a nucleoside-sparing regimen consisting of lopinavir/ritonavir + raltegravir (RLT). ? To compare the antiviral efficacy of LPV/r +FTC/TDF and LPV/r+RLT after 48 weeks of treatment.;Secondary Objective: ? To compare antiviral efficacy of LPV/r +FTC/TDF and LPV/r+RLT at 96 weeks of treatment. ? To compare viral decay rates between LPV/r +FTC/TDF and LPV/r+RLT. ? To characterize the development of resistance in the two treatment groups. ? To compare the population pharmacokinetics of lopinavir and ritonavir between the LPV/r +FTC/TDF and LPV/r+RLT regimens. ? To compare the effect of LPV/r +FTC/TDF and LPV/r+RLT on metabolic and somatic parameters. ? To compare the effect of LPV/r +FTC/TDF and LPV/r+RLT on patient reported outcomes.;Primary end point(s): The proportion of subjects with HIV-1 RNA < 50 copies/mL at 48 weeks | — |
Countries
France, Italy, Spain
Outcome results
None listed