NCT00669487|CompletedPhase 3DMC
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Sponsor study identifier
interventional
150
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
April 2011
Actual (reported)This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
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.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2008
Actual (reported)April 30, 2008
Actual (reported)December 2010
Actual (reported)April 2011
Actual (reported)Change from baseline in mean hemoglobin at 24 weeks and 72 weeks
72 weeks
Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks
72 weeks
Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks
72 weeks
Change from baseline in serum creatinine at 24 weeks and 72 weeks
72 weeks
Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks
72 weeks
Change from baseline in CD4 count at 24 weeks and 72 weeks
72 weeks
Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72
GPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z
SEARCH Thailand
Bangkok, Bangkok, 10330, Thailand
Jintanat - Ananworanich, M.D.
SEARCH Thailand
Jintanat - Ananworanich, M.D., Ph.D
SEARCH Thailand
150 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2008
First Posted
April 30, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
GPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2010
Actual (reported)Study Completion
April 2011
Actual (reported)Last Updated
May 28, 2015
Record last verified: 2015-05
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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