HIV, HIV Associated Lipodystrophy Syndrome., Hypercholesterolemia, Lipoatrophy
Conditions
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.
Interventions
DRUGDifferent HAART regimens
Sponsors
Odense University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital
Danish HIV Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 adverse events. | — |
| 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 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. | — |
| Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination. | — |
Countries
Denmark
Outcome results
None listed