NCT00686270

Brief Summary

This study will examine the long term safety of apricitabine in HIV-1 infected patients from studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and consequently wish to withdraw early from studies AVX-301 or AVX-302.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Typical duration for phase_3 hiv-infections

Status
withdrawn

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

May 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

May 27, 2008

Last Update Submit

June 22, 2011

Conditions

HIV Infections

Keywords

HIV-1 infectionNRTI resistanceM184V mutationreverse transcriptaseapricitabinedrug resistancesafety and tolerabilitytherapy failureTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • The number, type and severity of SAEs occuring during the study

    Week 96

Study Arms (1)

1

EXPERIMENTAL

apricitabine

Drug: apricitabine

Interventions

apricitabineDRUG

Initially 1200mg apricitabine twice daily orally. Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.

Also known as: ATC, AVX754
1

Eligibility Criteria

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

You may qualify if:

  • Patients who complete studies AVX-301 or AVX-302 or :Patients who meet the criteria for virologic failure/lack of response in study AVX-301 or AVX-302
  • years of age, or older
  • Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol.

You may not qualify if:

  • Prior withdrawal from AVX-301 or AVX-302
  • Current acute or chronic hepatitis B virus infection
  • Current treatment for hepatitis C virus infection
  • Renal Function not adequate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Mike Saag, Professor

    UAB Centre for AIDS Research, Birmingham, Alabama, 35294-2050, USA

    PRINCIPAL INVESTIGATOR

  • Susan W Cox, PhD

    Avexa Ltd

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 23, 2011

Record last verified: 2011-06