| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-Infected Patients | ||||||||
| Official Title † | |||||||||
| Brief Summary | To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients |
||||||||
| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Parallel Assignment | ||||||||
| Primary Outcome Measure † | Renal function measured by Cystatin-C and creatinine clearance [ Time Frame: Weeks 0, 4, 8, 12, 24, 24, 48, 96 ] [ Designated as safety issue: Yes ] Levels of renal tubule function markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Bone mass assessed by DEXA [ Time Frame: Weeks 0, 24, 48, 96 ] [ Designated as safety issue: Yes ] Levels of bone turnover markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Insulin resistance [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Changes in body composition assessed by patient questionnaire and standardized examination by physician [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Changes in subcutaneous adipose tissue assessed by DEXA [ Time Frame: Week 0, 24, 48, 96 ] [ Designated as safety issue: Yes ] |
||||||||
| Secondary Outcome Measure † | Patients with viral load < 40 copies/ml [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] CD-4 cell count [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Fasting triglycerides, HDL and LDL [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Development of resistance mutations [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] Development of adverse events and serious adverse events [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ] |
||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | Drug: Tenofovir disoproxil fumarate Drug: Abacavir |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 90 | ||||||||
| Start Date † | April 2008 | ||||||||
| Completion Date | February 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | Denmark | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00647244 | ||||||||
| Organization ID | SKS-HIV-002 | ||||||||
| Secondary IDs †† | EudraCT2007-004372-39 | ||||||||
| Study Sponsor † | Aarhus University Hospital | ||||||||
| Collaborators †† | |||||||||
| Investigators † | |||||||||
| Information Provided By | University of Aarhus | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | March 26, 2008 | ||||||||
| Last Updated Date | March 28, 2008 | ||||||||
|
