Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Hvidovre 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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Different HAART regimens | Drug |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Gerstoft, M.D., DMSc | Rigshospitalet, Denmark | Principal Investigator |
| Ann-Brit E Hansen, M.D. | Odense University Hospital | Principal Investigator |
| Court Pedersen, Professor | Odense University Hospital | Principal Investigator |
| Lars Mathiesen, M.D. DMSc | Hvidovre University Hospital | Principal Investigator |
| Alex Laursen, D.M., DMSc | Aarhus University Hospital | Principal Investigator |
| Niels Obel | Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, Aarhus University Hospital | Aarhus | 8200 | Denmark | |||
| Department of Infectious Diseases, Rigshospitalet |
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| Copenhagen |
| 2100 |
| Denmark |
| Department of Infectious Diseases, Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| Department of Infectious diseases, Odense University Hospital | Odense | 5000 | Denmark |
| ID | Term |
|---|---|
| D039682 | HIV-Associated Lipodystrophy Syndrome |
| D006937 | Hypercholesterolemia |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
Not provided
Not provided