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Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients (SWAP)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
Abacavir
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Tenofovir, Abacavir, Antiretroviral therapy, HIV, Nucleoside analogue reverse transcriptase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Tenofovir

Abacavir

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
March 26, 2008
Last Updated
December 17, 2010
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00647244
Brief Title
Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients
Acronym
SWAP
Official Title
Efficacy and Safety of Switching From AZT to Tenofovir
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Tenofovir, Abacavir, Antiretroviral therapy, HIV, Nucleoside analogue reverse transcriptase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Tenofovir
Arm Title
2
Arm Type
Active Comparator
Arm Description
Abacavir
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Intervention Description
Tenofovir disoproxil 245 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Abacavir
Intervention Description
Abacavir 300 mg oral tablet twice daily
Primary Outcome Measure Information:
Title
Renal function measured by Cystatin-C and creatinine clearance
Time Frame
Weeks 0, 4, 8, 12, 24, 24, 48, 96
Title
Levels of renal tubule function markers in blood and urine
Time Frame
Weeks 0, 12, 24, 48, 96
Title
Bone mass assessed by DEXA
Time Frame
Weeks 0, 24, 48, 96
Title
Levels of bone turnover markers in blood and urine
Time Frame
Weeks 0, 12, 24, 48, 96
Title
Insulin resistance
Time Frame
Weeks 0, 12, 24, 48, 96
Title
Changes in body composition assessed by patient questionnaire and standardized examination by physician
Time Frame
Weeks 0, 12, 24, 48, 96
Title
Changes in subcutaneous adipose tissue assessed by DEXA
Time Frame
Week 0, 24, 48, 96
Secondary Outcome Measure Information:
Title
Patients with viral load < 40 copies/ml
Time Frame
Weeks 0, 4, 8, 12, 24, 48, 96
Title
CD-4 cell count
Time Frame
Weeks 0, 4, 8, 12, 24, 48, 96
Title
Fasting triglycerides, HDL and LDL
Time Frame
Weeks 0, 12, 24, 48, 96
Title
Development of resistance mutations
Time Frame
Weeks 0, 12, 24, 48, 96
Title
Development of adverse events and serious adverse events
Time Frame
Weeks 0, 4, 8, 12, 24, 48, 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Århus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22479327
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.
Results Reference
derived
PubMed Identifier
21970555
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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients

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