Once Daily 3TC, Efavirenz and ddI for HIV Infection
Recruitment status was Recruiting
|First Received Date ICMJE||September 16, 2005|
|Last Updated Date||October 21, 2005|
|Start Date ICMJE||May 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||- levels of adherence|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00214435 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Once Daily 3TC, Efavirenz and ddI for HIV Infection|
|Official Title ICMJE||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|
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.
Rationale: ‘TEddI’ will enable a once-daily treatment strategy to be studied and provide information on effectiveness, patient adherence and quality of life and the tolerability of such regimens.
Hypothesis: The study hypothesis is that an antiretroviral regimen comprising of three agents taken once daily will have higher levels of adherence than a regimen requiring more frequent dosing.
Primary objective: To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomised to receive either a once daily minimum 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.
Secondary objectives: The secondary objectives of the study will include:
One hundred and twenty (120) subjects will be recruited and randomised in a 1:1 ratio to one of two open-label treatment regimens and will continue to receive randomised treatment until week 24:
Arm 1: (Once daily arm) commence treatment with a once-a-day combination of licensed antiviral medications (such as EFV/ddI/3TC, EFV/3TC/TDF or ATV/3TC/TDF).
Arm 2: (Continuation arm) continue current ART (minimum 3-drugs) dosed twice daily or more frequently
Following week 24, patients will have the option to continue randomised treatment for a further 24 weeks or switch to the once daily treatment arm. In all cases, patients will be followed up for 48 weeks from the baseline visit.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: once daily minimum 3-drug regimen of anti-retroviral medications|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Australia|
|NCT Number ICMJE||NCT00214435|
|Other Study ID Numbers ICMJE||TEddI|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||407 Doctors|
|Information Provided By||407 Doctors|
|Verification Date||September 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP