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

This study has been completed.
Information provided by:
University of Aarhus Identifier:
First received: March 26, 2008
Last updated: December 17, 2010
Last verified: December 2010
To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients

Condition Intervention Phase
HIV Infections
Drug: Tenofovir disoproxil fumarate
Drug: Abacavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Switching From AZT to Tenofovir

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Renal function measured by Cystatin-C and creatinine clearance [ Time Frame: Weeks 0, 4, 8, 12, 24, 24, 48, 96 ]
  • Levels of renal tubule function markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Bone mass assessed by DEXA [ Time Frame: Weeks 0, 24, 48, 96 ]
  • Levels of bone turnover markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Insulin resistance [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Changes in body composition assessed by patient questionnaire and standardized examination by physician [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Changes in subcutaneous adipose tissue assessed by DEXA [ Time Frame: Week 0, 24, 48, 96 ]

Secondary Outcome Measures:
  • Patients with viral load < 40 copies/ml [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
  • CD-4 cell count [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]
  • Fasting triglycerides, HDL and LDL [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Development of resistance mutations [ Time Frame: Weeks 0, 12, 24, 48, 96 ]
  • Development of adverse events and serious adverse events [ Time Frame: Weeks 0, 4, 8, 12, 24, 48, 96 ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
Active Comparator: 2
Drug: Abacavir
Abacavir 300 mg oral tablet twice daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00647244

Aarhus University Hospital
Århus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alex Lund Laursen, MD, PhD, DmSC, Department of Infectious Diseases, Aarhus University Hospital, Denmark Identifier: NCT00647244     History of Changes
Other Study ID Numbers: SKS-HIV-002
Study First Received: March 26, 2008
Last Updated: December 17, 2010

Keywords provided by University of Aarhus:
Antiretroviral therapy
Nucleoside analogue reverse transcriptase inhibitor

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antimetabolites processed this record on May 25, 2017