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

NCT00988039 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1277

Last updated 2014-04-04

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus
  • HIV

Interventions

DRUG

Aluvia + 2NRTIs

Aluvia (lopinavir/ritonavir 400mg/100mg), twice daily The choice of NRTIs will be at the discretion of the managing clinician and based on the local standard of care and drug availability, taking into account patient's previous drug exposure and side effects on first-line therapy.

DRUG

Aluvia + raltegravir

Aluvia (lopinavir/ritonavir 400mg/100mg) twice daily raltegravir (400mg) twice daily

DRUG

Aluvia monotherapy

Aluvia (lopinavir/ritonavir 400mg/100mg) twice daily raltegravir (400mg) twice daily for the first 12 weeks only

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Justine Boles

    lead OTHER_GOV

Principal Investigators

  • Nicholas Paton, MD FRCP · MRC CTU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Kenya
  • Malawi
  • Uganda
  • Zambia
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988039 on ClinicalTrials.gov