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Completed

NCT Number: NCT00367952

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

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

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Avexa (co-ordinating sites in Australia and Argentina)

Melbourne, Victoria, 3121, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

apricitabine

Drug

800mg apricitabine twice daily orally for 96 weeks

Primary outcomes

  1. Time to virological failure (DHSS definition)

    Time frame: week 144

  2. incidence of AEs and laboratory abnormalities

    Time frame: Week 144

  3. time to withdrawal due to AEs

    Time frame: Week 144

Secondary outcomes

  1. Change from baseline HIV RNA

    Time frame: weeks 72, 96, 120, and 144

  2. Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml

    Time frame: at weeks 72, 96, 120, and 144

  3. Change from baseline and change in ratio of CD4+ and CD8+ counts

    Time frame: at weeks 72, 96, 120, and 144

Sponsors and collaborators

Lead sponsor

Avexa

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 24, 2006
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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