Chronic HIV infection MedDRA version: 12.0 Level: LLT Classification code 10008919 Term: Chronic HIV infection
Conditions
Interventions
Trade Name: KALETRA
Product Name: KALETRA
Pharmaceutical Form: Tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725170
Sponsors
National Centre in HIV Epidemiology and Clinical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1 positive by licensed diagnostic test 2. Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate) 3. Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for = 24 weeks 4. No change in antiretroviral therapy within 12 weeks prior to screening 5. Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (=7 days apart) HIV RNA results of >500 copies/mL 6. No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors 7. Able to provide written informed consent Are the trial subjects under 18? yes 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The following laboratory variables: a) absolute neutrophil count (ANC) 5 x ULN 2. Pregnant or nursing mothers 3. Patients with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen 4. Use of immunomodulators within 30 days prior to screening 5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John’s wort) 6. Intercurrent illness requiring hospitalisation 7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator 8. Patients with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study 9. Patients deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of patients with HIV RNA <200 copies/mL 48 weeks after randomisation. ; Secondary Objective: A number of secondary outcomes will be assessed which are of relevance and interest in the assessment of the performance of the two study treatment regimens. These will include (but will not necessarily be limited to) virological, immunological, safety and antiretroviral treatment change. In addition some exploratory objectives will also be examined including clinical, metabolic, anthropometric, medication adherence and quality of life. ;Primary end point(s): To compare the virological efficacy of the two regimens as measured by the proportion of participants with HIV RNA <200 copies/mL 48-weeks and 96 weeks after randomisation in the intention-to-treat (ITT) population. | — |
Countries
France, Germany, Ireland, United Kingdom
Outcome results
None listed