NCT00367172|CompletedDMC
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Sponsor study identifier
Secondary identifiers
NIH
interventional
125
1 country
1
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Study Completion
December 2006
Actual (reported)The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2006
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.
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
June 2006
Actual (reported)August 21, 2006
Actual (reported)August 22, 2006
Actual (reported)December 2006
Actual (reported)Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.
Mean change in HIV-1 viral load from baseline to six months at the end of the intervention.
Virological Success at six months following the termination of the intervention.
3-Day Recall measures of adherence at the end of six months on the intervention.
Mean change in HIV-1 viral load from baseline six months following the termination of the intervention.
Mean change in CD4+ T cells from baseline to the end of six months on the intervention.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Altice FL, Mezger JA, Hodges J, Bruce RD, Marinovich A, Walton M, Springer SA, Friedland GH. Developing a directly administered antiretroviral therapy intervention for HIV-infected drug users: implications for program replication. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S376-87. doi: 10.1086/421400.
Altice FL, Maru DS, Bruce RD, Springer SA, Friedland GH. Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial. Clin Infect Dis. 2007 Sep 15;45(6):770-8. doi: 10.1086/521166. Epub 2007 Aug 13.
Frederick L Altice, M.D.
Yale University
Gerald H Friedland
Yale University
First Submitted
August 21, 2006
First Posted
August 22, 2006
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Family Spirit Study
Contact the study team to confirm eligibility.
Study Completion
December 2006
Actual (reported)Last Updated
March 31, 2020
Record last verified: 2009-08
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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