Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-Infected Patients - Full Text View

Sponsor:	Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00647244

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Efficacy and Safety of Switching From AZT to Tenofovir

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Abacavir Tenofovir Abacavir sulfate Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

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 ]

Estimated Enrollment:	90
Study Start Date:	June 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Tenofovir	Drug: Tenofovir disoproxil fumarate Tenofovir disoproxil 245 mg oral tablet once daily
2: Active Comparator 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

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

Contacts

Contact: Alex Lund Laursen, MD, PhD, DmSC	+4589498305	ale@sks.aaa.dk
Contact: Lars Ostergaard, MD, PhD, DmSC	+4589498300

Locations

Denmark
Aarhus University Hospital	Recruiting
Århus N, Denmark, 8200
Contact: Alex Lund Laursen, MD, PhD, DmSC +4589498305 ale@sks.aaa.dk
Principal Investigator: Alex Lund Laursen, MD, PhD, DmSC
Sub-Investigator: Lars Ostergaard, MD, PhD, DmSC
Sub-Investigator: Carsten Schade Larsen, MD, PhD, DmSC

Sponsors and Collaborators

Aarhus University Hospital

More Information

No publications provided

Responsible Party:	Department of Infectious Diseases, Aarhus University Hospital, Denmark ( Alex Lund Laursen, MD, PhD, DmSC )
Study ID Numbers:	SKS-HIV-002, EudraCT2007-004372-39
Study First Received:	March 26, 2008
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00647244 History of Changes
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:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 30, 2009