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

HIV Infection Clinical Trial

Official title:

An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367952
• Other study ID #: AVX-201E
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2006
• Last updated: June 22, 2011
• Start date: August 2006
• Est. completion date: January 2010

Study information

• Verified date: June 2011
• Source: Avexa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• apricitabine
800mg apricitabine twice daily orally for 96 weeks

Locations

Country	Name	City	State
Australia	Avexa (co-ordinating sites in Australia and Argentina)	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Avexa

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to virological failure (DHSS definition)		week 144	No
Primary	incidence of AEs and laboratory abnormalities		Week 144	Yes
Primary	time to withdrawal due to AEs		Week 144	Yes
Secondary	Change from baseline HIV RNA		weeks 72, 96, 120, and 144	No
Secondary	Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml		at weeks 72, 96, 120, and 144	No
Secondary	Change from baseline and change in ratio of CD4+ and CD8+ counts		at weeks 72, 96, 120, and 144	No