NCT00931463

A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen

A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir. The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks. The primary endpoint is virological: a comparison of virological suppression in plasma \< 200 copies/mL between the randomized arms after 48 weeks. Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.

Detailed description

In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs. Eligible patients will be randomised to one of two arms: I. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA \< 200 copies/mL 48 weeks after randomisation. Secondary objectives include virological, immunological, safety and antiretroviral therapy endpoints. Exploratory endpoints include clinical, metabolic, drug resistance, medication adherence and quality of life endpoints.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	raltegravir	400 mg raltegravir tablet taken every 12 hours
DRUG	2N(t)RTI	2N(t)RTIs as prescribed
DRUG	Ritonavir-boosted lopinavir	2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-09-01
• Completion: 2013-08-01
• First posted: 2009-07-02
• Last updated: 2026-03-27
• Results posted: 2014-01-17

Locations

44 sites across 17 countries: Argentina, Australia, Chile, France, Germany, Hong Kong, India, Ireland, Malaysia, Mexico, New Zealand, Nigeria, Peru, Singapore, South Africa, Taiwan, United Kingdom