Overview

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

Status:
Completed

Trial end date:
2013-08-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Kirby Institute

Collaborators:

Abbott
amfAR, The Foundation for AIDS Research
Merck Sharp & Dohme Corp.

Treatments:

Lopinavir
Raltegravir Potassium
Reverse Transcriptase Inhibitors
Ritonavir