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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Avexa:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Other Name: apricitabine

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367952

Locations
Australia, Victoria
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

No publications provided

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
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Avexa:
HIV
apricitabine
drug resistance
reverse transcriptase
lamivudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013