Europe-Africa Research Network for Evaluation of Second-line Therapy

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good clinical outcome following WHO-defined failure on a first-line nucleoside reverse transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and NNRTI resistance mutations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Justine Boles
• Collaborator: European and Developing Countries Clinical Trials Partnership (EDCTP)
• Treatments: Lopinavir; Raltegravir Potassium

Criteria

Inclusion Criteria:

• Previously documented HIV infection on at least one standard antibody-based test

• Age 12 years and above

• Taking 2NRTI + NNRTI-based regimen continuously for at least 12 months

• Naive to protease inhibitor therapy

• Good adherence to ART in the 12 weeks prior to screening defined as missing medication on no more than 3 days in the prior month

• Clinically stable and receiving treatment for any known opportunistic infections

• HIV treatment failure defined by one or more of clinical, immunological or virological criteria defined in the protocol, including VL and CD4 at screening visit

• Willing and able to give informed consent

• Able to attend for regular study follow up visits

Exclusion Criteria:

• Any major clinical contra-indications to the use of bPI, the NRTIs that are available to be selected for a second-line regimen or raltegravir

• Known Hepatitis B carrier (Hepatitis B surface antigen positive if tested)

• Requires concomitant medication with known major interactions with study drugs for which drug substitutions or dose alterations are not available or acceptable

• Women who are currently pregnant or breastfeeding

• Current participation in another clinical trial involving a treatment intervention (may be permitted in some circumstances, but must be discussed with MRC CTU)

• Life expectancy of less than one month in the opinion of the treating physician