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

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ClinicalTrials.gov Identifier: NCT00647244
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
University of Aarhus

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir disoproxil fumarate Drug: Abacavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Switching From AZT to Tenofovir
Study Start Date : June 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Tenofovir
 Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil 245 mg oral tablet once daily
Active Comparator: 2
Abacavir
 Drug: Abacavir
Abacavir 300 mg oral tablet twice daily


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647244


Locations
Denmark
Aarhus University Hospital
Århus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alex Lund Laursen, MD, PhD, DmSC, Department of Infectious Diseases, Aarhus University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00647244     History of Changes
Other Study ID Numbers: SKS-HIV-002
EudraCT2007-004372-39
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: December 2010

Keywords provided by University of Aarhus:
Tenofovir
Abacavir
Antiretroviral therapy
HIV
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
Tenofovir
Abacavir
 Dideoxynucleosides
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