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A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study

NCT00192634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2011-05-25

No results posted yet for this study

Summary

Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety.

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine 200mg - Tenofovir 300mg

1 tablet once daily for 96 weeks

DRUG

Abacavir 600mg - Lamivudine 300mg

1 tablet once daily for 96 weeks

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Andrew Carr, MD FRACP FRCPA · Kirby Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Australia

Study Locations

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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 NCT00192634 on ClinicalTrials.gov