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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 clearance

Levels 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/ml

CD-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

Page last updated: August 23, 2015

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