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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV, HIV Associated Lipodystrophy Syndrome., Hypercholesterolemia, Lipoatrophy

Intervention / Treatment
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* Drug: Different HAART regimens


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Different HAART regimens|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |