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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00214435




Registration number
NCT00214435
Ethics application status
Date submitted
16/09/2005
Date registered
22/09/2005
Date last updated
25/10/2005

Titles & IDs
Public title
Once Daily 3TC, Efavirenz and ddI for HIV Infection
Scientific title
A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine, Efavirenz and Didanosine Versus Continuation of Current Anti-Retroviral Regimen Delivered at Least Twice Daily
Secondary ID [1] 0 0
TEddI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
AIDS 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - once daily minimum 3-drug regimen of anti-retroviral medications

Treatment: Drugs: once daily minimum 3-drug regimen of anti-retroviral medications
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
- levels of adherence
Timepoint [1] 0 0
Secondary outcome [1] 0 0
- proportion of patients with treatment failure where treatment failure is defined
Timepoint [1] 0 0
Secondary outcome [2] 0 0
- 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)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- proportion of patients with plasma HIV-RNA less than 50 copies/ml (using an ultrasensitive assay) at 24 and 48 weeks
Timepoint [3] 0 0
Secondary outcome [4] 0 0
- change from baseline in CD4 cell count at 24 and 48 weeks
Timepoint [4] 0 0
Secondary outcome [5] 0 0
- changes from baseline in subjects' quality of life at 24 and 48 weeks
Timepoint [5] 0 0
Secondary outcome [6] 0 0
- changes from baseline based on DASS 21 scores at 24 and 48 weeks
Timepoint [6] 0 0
Secondary outcome [7] 0 0
- incidence and severity of adverse events and abnormal
Timepoint [7] 0 0
Secondary outcome [8] 0 0
- laboratory values (grade 3 & 4) at 24 and 48 weeks
Timepoint [8] 0 0
Secondary outcome [9] 0 0
- proportion of patients remaining on assigned treatment
Timepoint [9] 0 0

Eligibility
Key inclusion criteria
- 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 ß-HCG pregnancy
test within 14 days prior to week -4 (assessment of study eligibility)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
407 Doctors - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
407 Doctors
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Merck Sharp & Dohme LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00214435
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Baker, MB ChB
Address 0 0
407 Doctors
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David A Baker, MB ChB
Address 0 0
Country 0 0
Phone 0 0
02 9332 2531
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00214435