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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT2007-004372-39 |
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To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Tenofovir |
|
| 2 | Active Comparator | Abacavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate | Drug | Tenofovir disoproxil 245 mg oral tablet once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function measured by Cystatin-C and creatinine clearance | Weeks 0, 4, 8, 12, 24, 24, 48, 96 | |
| Levels of renal tubule function markers in blood and urine | Weeks 0, 12, 24, 48, 96 | |
| Bone mass assessed by DEXA | Weeks 0, 24, 48, 96 | |
| Levels of bone turnover markers in blood and urine | Weeks 0, 12, 24, 48, 96 | |
| Insulin resistance | Weeks 0, 12, 24, 48, 96 | |
| Changes in body composition assessed by patient questionnaire and standardized examination by physician | Weeks 0, 12, 24, 48, 96 | |
| Changes in subcutaneous adipose tissue assessed by DEXA | Week 0, 24, 48, 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with viral load < 40 copies/ml | Weeks 0, 4, 8, 12, 24, 48, 96 | |
| CD-4 cell count | Weeks 0, 4, 8, 12, 24, 48, 96 | |
| Fasting triglycerides, HDL and LDL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Århus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22479327 | Derived | Rasmussen TA, Jensen D, Tolstrup M, Nielsen US, Erlandsen EJ, Birn H, Ostergaard L, Langdahl BL, Laursen AL. Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial. PLoS One. 2012;7(3):e32445. doi: 10.1371/journal.pone.0032445. Epub 2012 Mar 29. | |
| 21970555 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C106538 | abacavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Abacavir |
| Drug |
Abacavir 300 mg oral tablet twice daily |
|
| Weeks 0, 12, 24, 48, 96 |
| Development of resistance mutations | Weeks 0, 12, 24, 48, 96 |
| Development of adverse events and serious adverse events | Weeks 0, 4, 8, 12, 24, 48, 96 |
| Rasmussen TA, Tolstrup M, Melchjorsen J, Frederiksen CA, Nielsen US, Langdahl BL, Ostergaard L, Laursen AL. Evaluation of cardiovascular biomarkers in HIV-infected patients switching to abacavir or tenofovir based therapy. BMC Infect Dis. 2011 Oct 4;11:267. doi: 10.1186/1471-2334-11-267. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |