NCT00367952

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

3.4 years

First QC Date

August 22, 2006

Last Update Submit

June 22, 2011

Conditions

HIV Infection

Keywords

HIVapricitabinedrug resistancereverse transcriptaselamivudine

Outcome Measures

Primary Outcomes (3)

  • Time to virological failure (DHSS definition)

    week 144

  • incidence of AEs and laboratory abnormalities

    Week 144

  • time to withdrawal due to AEs

    Week 144

Secondary Outcomes (3)

  • Change from baseline HIV RNA

    weeks 72, 96, 120, and 144

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

    at weeks 72, 96, 120, and 144

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

    at weeks 72, 96, 120, and 144

Study Arms (1)

ATC 800mg BID

EXPERIMENTAL

800mg ATC BID

Drug: apricitabine

Interventions

apricitabineDRUG

800mg apricitabine twice daily orally for 96 weeks

ATC 800mg BID

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed AVX-201 protocol, Plasma HIV RNA \<5000 copies/ml, CD4 cells \>50

You may not qualify if:

  • Pregnant or breastfeeding females, withdrawal from AVX-201

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avexa (co-ordinating sites in Australia and Argentina)

Melbourne, Victoria, 3121, Australia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

apricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Susan W Cox, Ph D

    Avexa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 24, 2006

Study Start

August 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

AU(1)