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

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:	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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 ]


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: 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 (Adult, Senior)
Sexes Eligible for Study:	All
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


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

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2017