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Once Daily 3TC, Efavirenz and ddI for HIV Infection

2014-08-27 03:49:10 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV Infection

Intervention

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

Location

407 Doctors
Sydney
New South Wales
Australia
2010

Status

Recruiting

Source

407 Doctors

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:49:10-0400

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Medical and Biotech [MESH] Definitions

Directions written to discontinue use of PRESCRIPTION DRUGS in order to reduce unnecessary and/or excessive medications (see POLYPHARMACY), DRUG SIDE EFFECTS and ADVERSE DRUG REACTION.

Improper use of drugs or medications outside the intended purpose, scope, or guidelines for use. This is in contrast to MEDICATION ADHERENCE, and distinguished from DRUG ABUSE, which is a deliberate or willful action.

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Agents used to treat RETROVIRIDAE INFECTIONS.

A condition associated with the use of certain medications and characterized by an internal sense of motor restlessness often described as an inability to resist the urge to move.

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