HIV-Associated Lipodystrophy Syndrome
Conditions
Keywords
HIV, Lipoatrophy, Lipodystrophy, Treatment Naive, HIV Infections, Hypercholesterolemia
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. There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy. The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen. The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.
Interventions
DRUGnucleoside analogue sparing HAART regimen
Sponsors
Rigshospitalet, Denmark
Hvidovre University Hospital
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Abbott
Danish HIV Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Antiretroviral naïve patients * HIV-1 infection as documented by a licensed HIV-1 antibody ELISA. * Fulfilling the criteria for starting antiretroviral therapy. * 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. * Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz. * 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 | — |
| Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination | — |
| Change from baseline in fasting lipids and subsets hereof | — |
| Development of impaired glucose tolerance and insulin resistance | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 randomized therapy and reasons for this | — |
| Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks | — |
| 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 | — |
| Incidence of genotypical and virological resistance | — |
| Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks | — |
| Incidence of adverse events | — |
| Incidence of clinical disease progression | — |
Countries
Denmark
Outcome results
None listed