Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tenofovir disoproxil fumarate (Drug); Abacavir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aarhus University Hospital
Summary
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in
HIV-infected patients
Clinical Details
Official title: Efficacy and Safety of Switching From AZT to Tenofovir
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Renal function measured by Cystatin-C and creatinine clearanceLevels of renal tubule function markers in blood and urine Bone mass assessed by DEXA Levels of bone turnover markers in blood and urine Insulin resistance Changes in body composition assessed by patient questionnaire and standardized examination by physician Changes in subcutaneous adipose tissue assessed by DEXA
Secondary outcome: Patients with viral load < 40 copies/mlCD-4 cell count Fasting triglycerides, HDL and LDL Development of resistance mutations Development of adverse events and serious adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Aarhus University Hospital, Ã…rhus N 8200, Denmark
Additional Information
Starting date: June 2008
Last updated: December 17, 2010
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