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

Primary Purpose

HIV Associated Lipodystrophy Syndrome., HIV, Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Different HAART regimens

About this trial

This is an interventional treatment trial for HIV Associated Lipodystrophy Syndrome.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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).

Sites / Locations

Department of Infectious Diseases, Aarhus University Hospital
Department of Infectious Diseases, Rigshospitalet
Department of Infectious Diseases, Hvidovre University Hospital
Department of Infectious diseases, Odense University Hospital

Outcomes

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.

Full Information

NCT ID

NCT00139178

First Posted

August 30, 2005

Last Updated

September 2, 2005

Sponsor

Danish HIV Research Group

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00139178

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Danish HIV Research Group

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Associated Lipodystrophy Syndrome., HIV, Hypercholesterolemia, Lipoatrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Different HAART regimens

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.

Title

Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.

Title

Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.

Title

Incidence of adverse events.

Title

Incidence of clinical disease progression.

Title

Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.

Title

Change in plasma lactate from baseline.

Title

Time to discontinuation of the allocated therapy and reasons for this.

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Overall Study Officials: