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Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

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ClinicalTrials.gov Identifier: NCT00135460
Recruitment Status : Unknown
Verified September 2005 by Danish HIV Research Group.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2005
Last Update Posted : March 14, 2006
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Hvidovre University Hospital
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Abbott
Information provided by:
Danish HIV Research Group

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 26, 2005
Last Update Posted Date March 14, 2006
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2005)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2005)
  • 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
  • Change in plasma lactate from baseline
  • Time to discontinuation of the randomized therapy and reasons for this
  • Incidence of genotypical and virological resistance
  • Development of osteopenia, judged by DEXA-scan
  • Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
  • 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
  • Change in plasma lactate from baseline.
  • Time to discontinuation of the randomized therapy and reasons for this.
  • Incidence of genotypical and virological resistance.
  • Development of osteopenia, judged by DEXA-scan.
  • Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
Official Title  ICMJE Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-Associated Lipodystrophy Syndrome
Intervention  ICMJE Drug: nucleoside analogue sparing HAART regimen
Study Arms  ICMJE Not Provided
Publications * 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 naïve adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: August 25, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Antiretroviral naïve patients
  • 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:

  • Women being pregnant or breast-feeding.
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00135460
Other Study ID Numbers  ICMJE 2612-2198
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Danish HIV Research Group
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Odense University Hospital
  • Aarhus University Hospital
  • Aalborg University Hospital
  • Abbott
Investigators  ICMJE
Study Chair: Jan Gerstoft, M.D., DMSc Rigshospitalet, Denmark
Principal Investigator: Niels Obel, M.D., DMSc Odense University Hospital
Principal Investigator: Court Pedersen, Professor Odense University Hospital
Principal Investigator: Lars Mathiesen, M.D.,DMSc Hvidovre University Hospital
Principal Investigator: Henrik Nielsen, M.D.,DMSc Aalborg University Hospital
Principal Investigator: Alex Laursen, M.D., DMSc Aarhus University City
Principal Investigator: Ann-Brit E Hansen, M.D. Copenhagen University Hospital Rigshospitalet and Odense University Hospital
PRS Account Danish HIV Research Group
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP