HIV InfectionPhase 4NCT00214435
Once Daily 3TC, Efavirenz and ddI for HIV Infection
A Phase 4 study testing once daily minimum 3-drug regimen of anti-retroviral medications in people with HIV Infection and AIDS, run by 407 Doctors at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, AIDS
- What is being tested?
- once daily minimum 3-drug regimen of anti-retroviral medications
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- May 2004to not given
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Robyn Vale, RN contact
Australia1 site, 1 recruiting
- Recruiting
407 Doctors
Sydney, New South Wales, 2010
David A Baker, MB ChB, 02 9332 2531, db@407.com.au
David A Baker, MB ChB
About this study
Official 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
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.
Read the detailed description
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:
- To estimate the proportion of patients with treatment failure where treatment failure is defined as:
- 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
- Changes from baseline based on DASS 21 scores at 24 and 48 weeks
- Incidence and severity of adverse events and abnormal laboratory values (grade 3 \& 4) at 24 and 48 weeks
- Proportion of patients remaining on assigned treatment Study Design This is a randomised, open-label, multi-centre, prospective, 48-week study comparing a 3 (or more) drug once-daily antiretroviral regimen with any 3 (or more) drug regimen in which at least 1 drug must be taken at least twice daily.
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.
- Conditions
- HIV Infection, AIDS
- Being tested
- once daily minimum 3-drug regimen of anti-retroviral medications
- Keywords
- HIV infection, AIDS, Adherence, MEMS caps, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
once daily minimum 3-drug regimen of anti-retroviral medicationsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
- changes from baseline based on DASS 21 scores at 24 and 48 weeks
- incidence and severity of adverse events and abnormal
- laboratory values (grade 3 & 4) at 24 and 48 weeks
- proportion of patients remaining on assigned treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- 407 Doctors
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Merck Sharp & Dohme LLC
- Investigators
- David A Baker, MB ChB, Principal investigator, 407 Doctors
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214435
- Sponsor's protocol ID
- TEddI
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 25 Oct 2005
- Results posted
- No