A Long Term, Safety Study of Apricitabine in HIV-infected... | NCT00367952

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

NCT00367952

Sponsor

Avexa

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

42Actual

Phase

Phase 2

Conditions

HIV Infection

Interventions

apricitabine

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Aug 22, 2006

First Submission Date that Met QC Criteria

Aug 23, 2006

First Posted Date

Aug 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATC 800mg BID	Experimental	800mg ATC BID	Drug: apricitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
apricitabine	Drug	800mg apricitabine twice daily orally for 96 weeks	ATC 800mg BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to virological failure (DHSS definition)		week 144
incidence of AEs and laboratory abnormalities		Week 144
time to withdrawal due to AEs		Week 144

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline HIV RNA		weeks 72, 96, 120, and 144
Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml		at weeks 72, 96, 120, and 144
Change from baseline and change in ratio of CD4+ and CD8+ counts

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan W Cox, Ph D	Avexa	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avexa (co-ordinating sites in Australia and Argentina)		Melbourne	Victoria	3121	Australia

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C508042	apricitabine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided