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

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

September 2, 2005

Start Date ^ICMJE

March 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00139178 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Associated Lipodystrophy Syndrome.
HIV
Hypercholesterolemia
Lipoatrophy

Intervention ^ICMJE

Drug: Different HAART regimens

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00139178

Other Study ID Numbers ^ICMJE

26122450

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Danish HIV Research Group

Collaborators ^ICMJE

Odense University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital

Investigators ^ICMJE

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

Information Provided By

Danish HIV Research Group

Verification Date

August 2005

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

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