None listed
Conditions
Brief summary
The study will measure how safe it is to continue with apricitabine treatment long term in people with HIV-1 infection who previously were treated with apricitabine for a shorter period in a previous study
Interventions
This study is an open label extension study of the long term safety of apricitabine in Human Immunodeficiency Virus Type 1 (HIV-1) infected subjects who have completed the AVX-201 study. Subjects will continue to receive 800mg apricitabine by mouth twice daily in addition to their other HIV medications for up to an additional 96 weeks (making 144 weeks in total). The study will measure the long term safety of continued apricitabine treatment in HIV-1 infected subjects who were part of the AVX-20
This study is an open label extension study of the long term safety of apricitabine in Human Immunodeficiency Virus Type 1 (HIV-1) infected subjects who have completed the AVX-201 study. Subjects will continue to receive 800mg apricitabine by mouth twice daily in addition to their other HIV medications for up to an additional 96 weeks (making 144 weeks in total). The study will measure the long term safety of continued apricitabine treatment in HIV-1 infected subjects who were part of the AVX-201 study.
Sponsors
Avexa Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
HIV-1 infected males and non-pregnant, non-lactating females, when they entered the preceding AVX-201 studyCompleted the AVX-201 studyPlasma viral load <5000 copies/mlCD4 cells >50.
Exclusion criteria
Withdrawal from AVX-201 study or major protocol violationfemale subjects who are pregnant or breastfeeding.
Outcome results
None listed