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Register:	ANZCTR
Last refreshed on:	11 June 2018
Main ID:	ACTRN12617000025336
Date of registration:	09/01/2017
Prospective Registration:	Yes
Primary sponsor:	Biotron Limited
Public title:	A study of the safety of 3 months treatment with BIT225 and Combination Antiretroviral Therapy (cART), in patients with Human Immunodeficiency Virus-1 (HIV-1), compared to cART alone, including measurement of the concentration of BIT225 in the blood and antiviral activity.
Scientific title:	A Phase 2 Intensification Study of BIT225, a Human Immunodeficiency Virus-1 Vpu Inhibitor, in HIV-1 Infected Individuals Initiating Combination Antiretroviral Therapy (cART).
Date of first enrolment:	19/04/2017
Target sample size:	36
Recruitment status:	Completed
URL:	http://www.anzctr.org.au/ACTRN12617000025336.aspx
Study type:	Interventional
Study design:	Randomised controlled trial Parallel
Phase:	Phase 2

Countries of recruitment

Contacts

Key inclusion & exclusion criteria

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus-1 infection

Intervention(s)

BIT225 100mg or 200mg, capsule(s) taken once daily (QD), oral, from Day 1 to Week 12.
All study participants will also receive Combination Antiretroviral Therapy (cART): Atripla, fixed dose combination tablet (Tenofovir disoproxil fumarate (TDF); 300mg / emtricitabine (FTC); 200mg / efavirenz (EFV); 600mg) taken once daily (QD), oral, from Day 1 to Week 12. At conclusion of the study treatment period, particpants will remain on cART as per standard treatment guidelines..
Capsule/tablet counts on return will be used to monitor adherence.

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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