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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Danish HIV Research Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Hvidovre University Hospital
Odense University Hospital
Aarhus University Hospital
Aalborg Universitetshospital
Abbott
Information provided by:
Danish HIV Research Group
ClinicalTrials.gov Identifier:
NCT00135460
First received: August 25, 2005
Last updated: March 13, 2006
Last verified: September 2005

August 25, 2005
March 13, 2006
June 2003
Not Provided
  • 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
  • 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
Complete list of historical versions of study NCT00135460 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
Not Provided
 
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-Associated Lipodystrophy Syndrome
Drug: nucleoside analogue sparing HAART regimen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
November 2007
Not Provided

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00135460
2612-2198
Not Provided
Not Provided
Danish HIV Research Group
  • Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Odense University Hospital
  • Aarhus University Hospital
  • Aalborg Universitetshospital
  • Abbott
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 Universitetshospital
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
Danish HIV Research Group
September 2005

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