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

Sponsor:	Danish HIV Research Group
Collaborators:	Odense University Hospital Rigshospitalet, Denmark Hvidovre University Hospital Aarhus University Hospital
Information provided by:	Danish HIV Research Group
ClinicalTrials.gov Identifier:	NCT00139178

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: AIDS Cholesterol

Drug Information available for: Zidovudine Lamivudine Abacavir Ritonavir Lopinavir

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, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Denmark, -
Department of Infectious Diseases, Rigshospitalet
Copenhagen, -, Denmark, 2100
Department of Infectious diseases, Odense University Hospital
Odense, -, Denmark, 5000
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, -, Denmark, 8200

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

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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors
Pathologic Processes
Anti-Retroviral Agents
Therapeutic Uses
Syndrome
Lipodystrophy
Hypercholesterolemia
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Dyslipidemias
RNA Virus Infections
Anti-HIV Agents
Disease
Metabolic Diseases
Hyperlipidemias
Skin Diseases
Immune System Diseases
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV-Associated Lipodystrophy Syndrome
HIV Infections

ClinicalTrials.gov processed this record on February 08, 2010