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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

NCT00931463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2026-03-27

Study results available
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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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • amfAR, The Foundation for AIDS Research

    collaborator OTHER

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • David A Cooper, MD · Kirby Institute

  • Brian Gazzard, MD · St. Stephen's Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2013-08-31

Countries

  • Argentina
  • Australia
  • Chile
  • France
  • Germany
  • Hong Kong
  • India
  • Ireland
  • Malaysia
  • Mexico
  • New Zealand
  • Nigeria
  • Peru
  • Singapore
  • South Africa
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00931463 on ClinicalTrials.gov