Clinical trial NCT00647244: Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
Official title: Efficacy and Safety of Switching From AZT to Tenofovir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Tenofovir
Abacavir
Antiretroviral therapy
HIV
Nucleoside analogue reverse transcriptase inhibitor
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients


Eligibility criteria: 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

Primary outcomes:
measure: Renal function measured by Cystatin-C and creatinine clearance
timeFrame: Weeks 0, 4, 8, 12, 24, 24, 48, 96
measure: Levels of renal tubule function markers in blood and urine
timeFrame: Weeks 0, 12, 24, 48, 96
measure: Bone mass assessed by DEXA
timeFrame: Weeks 0, 24, 48, 96
measure: Levels of bone turnover markers in blood and urine
timeFrame: Weeks 0, 12, 24, 48, 96
measure: Insulin resistance
timeFrame: Weeks 0, 12, 24, 48, 96
measure: Changes in body composition assessed by patient questionnaire and standardized examination by physician
timeFrame: Weeks 0, 12, 24, 48, 96
measure: Changes in subcutaneous adipose tissue assessed by DEXA
timeFrame: Week 0, 24, 48, 96
Secondary outcomes:
measure: Patients with viral load < 40 copies/ml
timeFrame: Weeks 0, 4, 8, 12, 24, 48, 96
measure: CD-4 cell count
timeFrame: Weeks 0, 4, 8, 12, 24, 48, 96
measure: Fasting triglycerides, HDL and LDL
timeFrame: Weeks 0, 12, 24, 48, 96
measure: Development of resistance mutations
timeFrame: Weeks 0, 12, 24, 48, 96
measure: Development of adverse events and serious adverse events
timeFrame: Weeks 0, 4, 8, 12, 24, 48, 96
Other outcomes:
Locations:
city: Århus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
citation: 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.
citation: 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.