Status:
UNKNOWN
Once Daily 3TC, Efavirenz and ddI for HIV Infection
Lead Sponsor:
407 Doctors
Collaborating Sponsors:
Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 a...
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. Hyp...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00214435
Start Date
May 1 2004
Last Update
October 25 2005
Active Locations (1)
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1
407 Doctors
Sydney, New South Wales, Australia, 2010