Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

This study has been completed.
Sponsor:
Collaborators:
Odense University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital
Information provided by:
Danish HIV Research Group
ClinicalTrials.gov Identifier:
NCT00139178
First received: August 30, 2005
Last updated: September 2, 2005
Last verified: August 2005

August 30, 2005
September 2, 2005
March 2004
Not Provided
Changes in peripheral fat mass, determined by DEXA-Changes Change from baseline in fasting lipids and subsets hereof. Development of impaired glucose tolerance and insulin resistance.
Same as current
Complete list of historical versions of study NCT00139178 on ClinicalTrials.gov Archive Site
  • Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
  • 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 allocated 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.
Same as current
Not Provided
Not Provided
 
Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities

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.

The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy.

We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir).

The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir.

The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Associated Lipodystrophy Syndrome.
  • HIV
  • Hypercholesterolemia
  • Lipoatrophy
Drug: Different HAART regimens
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2007
Not Provided

Inclusion Criteria:

  • Currently treated with lamivudine, zidovudine and abacavir
  • Viral load < 200 copies/ml
  • 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.
  • Creatinine > 200 mmol/l.
  • ALT or AST > 5 times upper normal value (200U/l).
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00139178
26122450
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Danish HIV Research Group
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Aarhus University Hospital
Principal Investigator: Jan Gerstoft, M.D., DMSc Rigshospitalet, Denmark
Principal Investigator: Ann-Brit E Hansen, M.D. Odense University Hospital
Principal Investigator: Court Pedersen, Professor Odense University Hospital
Principal Investigator: Lars Mathiesen, M.D. DMSc Hvidovre University Hospital
Principal Investigator: Alex Laursen, D.M., DMSc Aarhus University Hospital
Study Chair: Niels Obel Odense University Hospital
Danish HIV Research Group
August 2005

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