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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Aarhus University Hospital |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nucleoside analogue sparing HAART regimen | Drug |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Gerstoft, M.D., DMSc | Rigshospitalet, Denmark | Study Chair |
| Niels Obel, M.D., DMSc | Odense University Hospital | Principal Investigator |
| Court Pedersen, Professor | Odense University Hospital | Principal Investigator |
| Lars Mathiesen, M.D.,DMSc | Hvidovre University Hospital | Principal Investigator |
| Henrik Nielsen, M.D.,DMSc | Aalborg University Hospital | Principal Investigator |
| Alex Laursen, M.D., DMSc | Aarhus University City | Principal Investigator |
| Ann-Brit E Hansen, M.D. | Copenhagen University Hospital Rigshospitalet and Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, Hvidovre University Hospital | Hvidovre | Copenhagen | 2650 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28399815 | Derived | Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y. |
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| OTHER |
| Aalborg University Hospital | OTHER |
| Abbott | INDUSTRY |
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| 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 randomized 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 |
| Department of Infectious Diseases, Aalborg Hospital |
| Aalborg |
| Denmark |
| Department of Infectious Diseases, Aarhus University Hospital | Aarhus | 8200 | Denmark |
| Department of Infectious Diseases, Rigshospitalet | Copenhagen | 2100 | Denmark |
| Department of Infectious Diseases, Odense University Hospital | Odense | 5000 | Denmark |
| ID | Term |
|---|---|
| D039682 | HIV-Associated Lipodystrophy Syndrome |
| D008060 | Lipodystrophy |
| D015658 | HIV Infections |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
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