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KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects

NCT00549198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2011-04-12

Study results available
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Summary

Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives.

The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

Conditions

  • Infection, Human Immunodeficiency Virus I
  • HIV Infection

Interventions

DRUG

Abacavir/lamivudine and efavirenz

DRUG

Tenofovir/Emtricitabine and efavirenz

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Netherlands
  • Portugal
  • Spain
  • Switzerland
  • 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 NCT00549198 on ClinicalTrials.gov