Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Avexa


Information provided by (Responsible Party)
Avexa
ClinicalTrials.gov Identifier
NCT00367952

First received: August 22, 2006
Last updated: June 22, 2011
Last Verified: June 2011
History of Changes
Purpose

Purpose

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

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.

Eligibility

Eligibility

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

Criteria

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

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 ClinicalTrials.gov identifier: NCT00367952

Locations

Australia
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, Australia, 3121

Sponsors and Collaborators

Avexa

Investigators

Study Director: Susan W Cox, Ph D Avexa
More Information

More Information


Responsible Party: Susan Cox, Avexa  
ClinicalTrials.gov 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:

HIV
apricitabine
drug resistance
reverse transcriptase
lamivudine

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.