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

This study has been completed.
Sponsor:
Information provided by:
Avexa
ClinicalTrials.gov Identifier:
NCT00367952
First received: August 22, 2006
Last updated: June 22, 2011
Last verified: June 2011
History of Changes

August 22, 2006
June 22, 2011
August 2006
January 2010   (final data collection date for primary outcome measure)
  • Time to virological failure (DHSS definition) [ Time Frame: week 144 ] [ Designated as safety issue: No ]
  • incidence of AEs and laboratory abnormalities [ Time Frame: Week 144 ] [ Designated as safety issue: Yes ]
  • time to withdrawal due to AEs [ Time Frame: Week 144 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml [ Time Frame: at weeks 72, 96, 120, and 144 ] [ Designated as safety issue: No ]
  • Change from baseline and change in ratio of CD4+ and CD8+ counts [ Time Frame: at weeks 72, 96, 120, and 144 ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: apricitabine
800mg apricitabine twice daily orally for 96 weeks
Other Name: apricitabine
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00367952
AVX-201E
Yes
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