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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Associated Lipodystrophy Syndrome.
HIV
Hypercholesterolemia
Lipoatrophy
 Drug: Different HAART regimens
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danish HIV Research Group:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: March 2004
Estimated Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139178

Locations
Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Denmark, 8200
Department of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Department of Infectious diseases, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Danish HIV Research Group
Odense University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00139178     History of Changes
Other Study ID Numbers: 26122450
Study First Received: August 30, 2005
Last Updated: September 2, 2005
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hypercholesterolemia
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Zidovudine
Lamivudine
Abacavir
Ritonavir
Lopinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on March 03, 2013