NCT00214435

Brief Summary

Poor compliance is thought to be a major cause of treatment failure. The TEddI study is a randomised, multi-centre, open-label study in well-controlled treatment-experienced HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral therapy versus continuation of current anti-retroviral regimen delivered at least twice daily.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

October 25, 2005

Status Verified

September 1, 2005

First QC Date

September 16, 2005

Last Update Submit

October 21, 2005

Conditions

HIV InfectionAIDS

Keywords

HIV infectionAIDSAdherenceMEMS capsTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • - levels of adherence

Secondary Outcomes (9)

  • - proportion of patients with treatment failure where treatment failure is defined

  • - HIV-1 RNA viral load of >400 copies/ml on two consecutive occasions more than one month apart, OR discontinuation of treatment for any reason (where subsequent therapy does not comply with the study regimen change guidelines outlined in section 3.3.3)

  • - proportion of patients with plasma HIV-RNA less than 50 copies/ml (using an ultrasensitive assay) at 24 and 48 weeks

  • - change from baseline in CD4 cell count at 24 and 48 weeks

  • - changes from baseline in subjects' quality of life at 24 and 48 weeks

  • +4 more secondary outcomes

Interventions

once daily minimum 3-drug regimen of anti-retroviral medicationsDRUG

Eligibility Criteria

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

You may qualify if:

  • aged 18 years or more with laboratory evidence of HIV-1 infection
  • ability to understand and provide written informed consent to participate in the study
  • stable on current ART regimen for at least 3 months prior to screening.
  • plasma HIV-RNA less than 400 copies/ml at the screening visit.
  • women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to week -4 (assessment of study eligibility)

You may not qualify if:

  • virological failure of a proposed Once daily arm medication
  • a serious medical condition which may compromise the subject's safety, including an active AIDS-defining condition within the previous 6 months
  • known toxicities to any of the proposed Once daily arm medications
  • laboratory abnormalities at screening:
  • serum creatinine greater than twice the upper limit of normal (2 x upper limit of normal (ULN))
  • AST, ALT or alkaline phosphatase greater than 5 times the ULN
  • lactate greater than 2.5 x ULN
  • haemoglobin less than 9.5 g/dL
  • women who are pregnant or breast-feeding or who, if of child-bearing potential, are not willing to use adequate contraception (including barrier contraception)
  • patients who in the investigator's opinion are unlikely to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

407 Doctors

Sydney, New South Wales, 2010, Australia

RECRUITING

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • David A Baker, MB ChB

    407 Doctors

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Baker, MB ChB

CONTACT

02 9332 2531db@407.com.au

Robyn Vale, RN

CONTACT

02 9332 2531

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

May 1, 2004

Last Updated

October 25, 2005

Record last verified: 2005-09

Locations

AU(1)