NCT00135460|UnknownPhase 4
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Sponsor study identifier
interventional
100
1 country
5
Study Start
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy. The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen. The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
August 25, 2005
Actual (reported)August 26, 2005
Actual (reported)November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Changes in peripheral fat mass, determined by DEXA-changes
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Change from baseline in fasting lipids and subsets hereof
Development of impaired glucose tolerance and insulin resistance
Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
Incidence of adverse events
Incidence of clinical disease progression
Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Copenhagen, 2650, Denmark
Department of Infectious Diseases, Aalborg Hospital
Aalborg, Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, 8200, Denmark
Department of Infectious Diseases, Rigshospitalet
Copenhagen, 2100, Denmark
Department of Infectious Diseases, Odense University Hospital
Odense, 5000, Denmark
Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.
Jan Gerstoft, M.D., DMSc
Copenhagen University Hospital, Rigshospitalet
Niels Obel, M.D., DMSc
Odense University Hospital
Court Pedersen, Professor
Odense University Hospital
Lars Mathiesen, M.D.,DMSc
Hvidovre University Hospital
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
November 2007
Date type not reportedContact the study team to confirm eligibility.
Henrik Nielsen, M.D.,DMSc
Aalborg University Hospital
Alex Laursen, M.D., DMSc
Aarhus University City
Ann-Brit E Hansen, M.D.
Copenhagen University Hospital Rigshospitalet and Odense University Hospital
This date has not been verified as actual or estimated.
Last Updated
March 14, 2006
Record last verified: 2005-09
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Source: ClinicalTrials.gov.
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