A Long Term Safety Study of Apricitabine in HIV-infected Patients

This study has been withdrawn prior to enrollment.
(Study was withdrawn owing to Sponsor decision)
Sponsor:
Information provided by:
Avexa
ClinicalTrials.gov Identifier:
NCT00686270
First received: May 27, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

This study will examine the long term safety of apricitabine in HIV-1 infected patients from studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and consequently wish to withdraw early from studies AVX-301 or AVX-302.


Condition Intervention Phase
HIV Infections
Drug: apricitabine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open Label 96-week Extension Study of the Safety of Apricitabine in Treatment-experienced HIV-1 Infected Patients Who Have Completed Protocol AVX-301 or AVX-302 or Who Have Met the Criteria for Open-label Access to ATC Because of Virological Failure/Lack of Response

Resource links provided by NLM:


Further study details as provided by Avexa:

Primary Outcome Measures:
  • The number, type and severity of SAEs occuring during the study [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
apricitabine
Drug: apricitabine
Initially 1200mg apricitabine twice daily orally. Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.
Other Names:
  • apricitabine
  • ATC
  • AVX754

Detailed Description:

The clinical study AVX-301 studies the efficacy and safety of 800mg and 1200mg BID ATC in combination with an optimized background in patients who are HIV-1 infected and have failed treatment with emtricitabine or lamivudine and have confirmed M184V/I mutation. Patients who do not achieve at least a 0.5 log10 copies/mL decrease in plasma HIV RNA by Week 16, or who experience a >1.0 log10 copies/mL increase (confirmed on two separate occasions at least one week apart) in plasma HIV RNA from nadir at or after Week 16, are eligible for screening for entry into this study. In addition, patients who complete study AVX-301 are also eligible for screening. The clinical study AVX-302 is similar and studies the efficacy and safety of a single dose of ATC (determined in AVX-301). Patients in AVX-302 who experience virologic failure or lack of virologic response will similarly be eligible for screening for entry into this study. In addition, patients who complete study AVX-302 are also eligible for screening. This is a phase 3, open-label, multi-center study of up to 96 weeks duration. Patients will receive for up to 96 weeks open-label ATC, initially at a dose of 1200mg orally BID. Following selection of the optimum ATC dose in protocol AVX-301 and termination of one of the two ATC doses (800mg or 1200mg orally BID) in protocol AVX-301, patients in this protocol will be transferred to the optimum dose, if required. The total number of patients expected to be enrolled in studies AVX-301 and AVX-302 is approximately 1866 in total.Patients will receive ATC orally in combination with their existing ART. Background antiretroviral therapy (ART) may be revised at any time during the study at the discretion of the investigator but must not include lamivudine, emtricitabine, zalcitabine or any other deoxycytidine analogue NRTI. The study will examine the safety and tolerability of long term treatment with apricitabine in combination with other ART.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who complete studies AVX-301 or AVX-302 or :Patients who meet the criteria for virologic failure/lack of response in study AVX-301 or AVX-302
  • 18 years of age, or older
  • Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion Criteria:

  • Prior withdrawal from AVX-301 or AVX-302
  • Current acute or chronic hepatitis B virus infection
  • Current treatment for hepatitis C virus infection
  • Renal Function not adequate
  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: NCT00686270

Sponsors and Collaborators
Avexa
Investigators
Principal Investigator: Mike Saag, Professor UAB Centre for AIDS Research, Birmingham, Alabama, 35294-2050, USA
Study Director: Susan W Cox, PhD Avexa Ltd
  More Information

No publications provided

Responsible Party: Susan Cox, Avexa Ltd
ClinicalTrials.gov Identifier: NCT00686270     History of Changes
Other Study ID Numbers: AVX-303
Study First Received: May 27, 2008
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Germany: Ministry of Health
Israel: Ministry of Health
Italy: Ministry of Health
Peru: Ministry of Health
South Africa: Department of Health
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Avexa:
HIV-1 infection
NRTI resistance
M184V mutation
reverse transcriptase
apricitabine
drug resistance
safety and tolerability
therapy failure
Treatment Experienced

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 July 29, 2014