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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00647244
First received: March 26, 2008
Last updated: December 17, 2010
Last verified: December 2010
  Purpose

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 ] [ Designated as safety issue: Yes ]
  • Levels of renal tubule function markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Bone mass assessed by DEXA [ Time Frame: Weeks 0, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Levels of bone turnover markers in blood and urine [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Insulin resistance [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Changes in body composition assessed by patient questionnaire and standardized examination by physician [ Time Frame: Weeks 0, 12, 24, 48, 96 ] [ Designated as safety issue: Yes ]
  • Changes in subcutaneous adipose tissue assessed by DEXA [ Time Frame: Week 0, 24, 48, 96 ] [ Designated as safety issue: Yes ]

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

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647244

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

No publications provided by University of Aarhus

Additional 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
Study First Received: March 26, 2008
Last Updated: December 17, 2010
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Tenofovir
Tenofovir disoproxil
Abacavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 31, 2014