Overview

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