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 Intervention Model: Parallel Assignment Masking: None (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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Abacavir

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 (Adult, Senior)
Sexes Eligible for Study:	All

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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 Ritonavir Lopinavir Lamivudine Zidovudine Abacavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents

ClinicalTrials.gov processed this record on September 21, 2017

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