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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367952
First Posted: August 24, 2006
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Avexa
August 22, 2006
August 24, 2006
June 23, 2011
August 2006
January 2010   (Final data collection date for primary outcome measure)
  • 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 ]
  • Time to virological failure (DHSS definition)
  • incidence of AEs and laboratory abnormalities
  • time to withdrawal due to AEs
Complete list of historical versions of study NCT00367952 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline HIV RNA at weeks 72, 96, 120, and 144
  • Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml at weeks 72, 96, 120, and 144
  • Change from baseline and change in ratio of CD4+ and CD8+ counts at weeks 72, 96, 120, and 144.
Not Provided
Not Provided
 
A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects
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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
Drug: apricitabine
800mg apricitabine twice daily orally for 96 weeks
Experimental: ATC 800mg BID
800mg ATC BID
Intervention: Drug: apricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00367952
AVX-201E
Yes
Not Provided
Not Provided
Susan Cox, Avexa
Avexa
Not Provided
Study Director: Susan W Cox, Ph D Avexa
Avexa
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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