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

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. Identifier: NCT00367952
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : June 23, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Drug: apricitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: ATC 800mg BID
800mg ATC BID
Drug: apricitabine
800mg apricitabine twice daily orally for 96 weeks

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Susan Cox, Avexa Identifier: NCT00367952     History of Changes
Other Study ID Numbers: AVX-201E
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 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