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

Avexa

Status and phase: Completed; Phase 2

Conditions: HIV Infection

Treatments: Drug: apricitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367952

AVX-201E

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

ATC 800mg BID

Experimental group

Description:

800mg ATC BID

Treatment:

Drug: apricitabine