Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
NCT ID: NCT00135460
Last Updated: 2006-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2003-06-30
2007-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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nucleoside analogue sparing HAART regimen
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
* Fulfilling the criteria for starting antiretroviral therapy.
* Ability to understand and provide written informed consent.
Exclusion Criteria
* Fertile women using no safe contraception.
* Patients with active intravenous drug use.
* Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.
* Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.
* Creatinine \> 200 mmol/l.
* ALT or AST \> 5 times upper normal value (200U/l).
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Hvidovre University Hospital
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Abbott
INDUSTRY
Danish HIV Research Group
OTHER
Principal Investigators
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Jan Gerstoft, M.D., DMSc
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Niels Obel, M.D., DMSc
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Court Pedersen, Professor
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Lars Mathiesen, M.D.,DMSc
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Henrik Nielsen, M.D.,DMSc
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Alex Laursen, M.D., DMSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University City
Ann-Brit E Hansen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital Rigshospitalet and Odense University Hospital
Locations
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Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark
Department of Infectious Diseases, Aalborg Hospital
Aalborg, , Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, , Denmark
Department of Infectious Diseases, Rigshospitalet
Copenhagen, , Denmark
Department of Infectious Diseases, Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Other Identifiers
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2612-2198
Identifier Type: -
Identifier Source: org_study_id