terminated
Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure
Sponsor study identifier
Secondary identifiers
NIH
interventional
24
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2007
Actual (reported)Study Completion
June 2007
Actual (reported)To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 24, 2006
Actual (reported)July 26, 2006
Actual (reported)June 2007
Actual (reported)June 2007
Actual (reported)Variations in the immune status of patients in each group throughout follow-up.
48 weeks
Percentage of patients that increase viral load by > 0.5 log
weeks 12, 24, 36 and 48
Percentage of patients that increase viral load by > 100,000 copies/mL
weeks 12, 24, 36 and 48
Percentage of patients that present some clinical event, B or C classification according to the CDC.
during the 48 weeks of follow-up
Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.
weeks 12, 24, 36 and 48
Percentage of patients that drop out of treatment.
weeks 12, 24, 36 and 48
Trizivir+ Tenofovir 2/day
antiretroviral treatment optimizated by genotyp
Trizivir (AZT+3HT+Abacavir) twice daily
Viread (300 mg Tenofovir disoproxil fumarate) once daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
H.U. Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Bonaventura Clotet, MD,PhD
LLuita contra la Sida Foundation-HIV Unit
24 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2006
First Posted
July 26, 2006
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2007
Actual (reported)Study Completion
June 2007
Actual (reported)Last Updated
January 29, 2008
Record last verified: 2007-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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