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

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

February 19, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647244 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy and Safety of Switching From AZT to Tenofovir

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Tenofovir disoproxil fumarate
Drug: Abacavir

Study Arms / Comparison Groups

Active Comparator: Tenofovir
Active Comparator: Abacavir

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2011

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00647244

Responsible Party

Alex Lund Laursen, MD, PhD, DmSC, Department of Infectious Diseases, Aarhus University Hospital, Denmark

Study ID Numbers ^ICMJE

SKS-HIV-002, EudraCT2007-004372-39

Study Sponsor ^ICMJE

Aarhus University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

University of Aarhus

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP