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A Long Term, Safety Study of Apricitabine in HIV-infected Subjects

This study has been completed.
Information provided by:
Avexa Identifier:
First received: August 22, 2006
Last updated: June 22, 2011
Last verified: June 2011
The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial

Condition Intervention Phase
HIV Infection Drug: apricitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects

Resource links provided by NLM:

Further study details as provided by Avexa:

Primary Outcome Measures:
  • Time to virological failure (DHSS definition) [ Time Frame: week 144 ]
  • incidence of AEs and laboratory abnormalities [ Time Frame: Week 144 ]
  • time to withdrawal due to AEs [ Time Frame: Week 144 ]

Secondary Outcome Measures:
  • Change from baseline HIV RNA [ Time Frame: weeks 72, 96, 120, and 144 ]
  • Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml [ Time Frame: at weeks 72, 96, 120, and 144 ]
  • Change from baseline and change in ratio of CD4+ and CD8+ counts [ Time Frame: at weeks 72, 96, 120, and 144 ]

Enrollment: 42
Study Start Date: August 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATC 800mg BID
800mg ATC BID
Drug: apricitabine
800mg apricitabine twice daily orally for 96 weeks

Detailed Description:

An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to 3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V mutation in reverse transcriptase. This extension study (AVX-201E) is available to patients who complete the AVX-201 protocol.

Patients will continue to receive apricitabine open label for a further 96 weeks (making a total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety markers and efficacy markers will be followed.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50

Exclusion Criteria:

  • Pregnant or breastfeeding females, withdrawal from AVX-201
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00367952

Australia, Victoria
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, Australia, 3121
Sponsors and Collaborators
Study Director: Susan W Cox, Ph D Avexa
  More Information

Responsible Party: Susan Cox, Avexa Identifier: NCT00367952     History of Changes
Other Study ID Numbers: AVX-201E
Study First Received: August 22, 2006
Last Updated: June 22, 2011

Keywords provided by Avexa:
drug resistance
reverse transcriptase

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on September 21, 2017