HIV Infections
Conditions
Keywords
Tenofovir, Abacavir, Antiretroviral therapy, HIV, Nucleoside analogue reverse transcriptase inhibitor
Brief summary
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients
Interventions
DRUGTenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
DRUGAbacavir
Abacavir 300 mg oral tablet twice daily
Sponsors
Aarhus University Hospital
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
* HIV-infection with undetectable viral load * Antiretroviral treatment including Retrovir for more than three months * If fertile female: Negative pregnancy test and use of safe contraception * Negative HBs-antigen titer
Exclusion criteria
* Prior treatment with abacavir or tenofovir * Resistance towards abacavir or tenofovir * Tissue type HLA-B5701 * Renal disease * Diabetes Mellitus * Osteoporosis * Pregnant or lactating subjects * Intravenous drug abuse * Hypersensitivity towards drugs or active ingredient used * ALAT \> 5 times upper normal level * Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in subcutaneous adipose tissue assessed by DEXA | Week 0, 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 |
| Renal function measured by Cystatin-C and creatinine clearance | Weeks 0, 4, 8, 12, 24, 24, 48, 96 |
Secondary
| Measure | Time frame |
|---|---|
| CD-4 cell count | Weeks 0, 4, 8, 12, 24, 48, 96 |
| Fasting triglycerides, HDL and LDL | 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 |
| Patients with viral load < 40 copies/ml | Weeks 0, 4, 8, 12, 24, 48, 96 |
Countries
Denmark
Outcome results
None listed