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Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection

NCT00612898 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2012-01-23

No results posted yet for this study

Summary

Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.

Conditions

  • HIV Infections

Interventions

DRUG

apricitabine

800mg BID apricitabine orally for 48 weeks

DRUG

lamivudine

150mg BID lamivudine orally for 48 weeks

Sponsors & Collaborators

  • Avexa

    lead INDUSTRY

Principal Investigators

  • Susan W Cox, Ph D · Avexa Ltd

  • Michael Saag, MD · UAB Center for AIDS Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Israel
  • Italy
  • Peru
  • Puerto Rico
  • Thailand
  • United Kingdom

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 NCT00612898 on ClinicalTrials.gov