A randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3 nucleoside reverse transcriptase inhibitors (NRTI) backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line non-nucleoside reverse transcriptase inhibitors (NNRTI)/2 NRTI therapy (the SECOND-LINE study). This study is for Human Immunodeficiency Virus (HIV) infection.
- Conditions
- Human Immunodeficiency Virus (HIV) -1 infectionInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12609000881235
- Lead Sponsor
- niversity of New South Wales/Kirby Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 550
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
1. The following laboratory variables
a) absolute neutrophil count (ANC) <500 cells/microlitres.
b) hemoglobin <7.0 g/dL
c) platelet count <50,000 cells/microlitres
d) Alanine transaminase (ALT) >5 x upper limit normal (ULN)
2. Pregnant or nursing mothers
3. Participants 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, St. John’s wort)
6. Intercurrent illness requiring hospitalisation
7. Active opportunistic disease not under adequate control in the opinion of the investigator
8. Participants with current alcohol or illicit substance abuse that in the opinion of the investigator might adversely affect participation in the study
9. Participants deemed by the investigator unlikely to be able to remain in follow-up for the protocol defined period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the virological efficacy of the two regimens as measured by the proportion of participants with HIV ribonucleic acid (RNA) <200 copies/mL 48-weeks and 96 weeks after randomisation in the intention-to-treat (ITT) population.[The primary analysis will summarise study variables when the last patient randomised has completed 48 weeks of follow-up.]
- Secondary Outcome Measures
Name Time Method