NCT00647244

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 20, 2010

Status Verified

December 1, 2010

Enrollment Period

2.2 years

First QC Date

March 26, 2008

Last Update Submit

December 17, 2010

Conditions

HIV Infections

Keywords

TenofovirAbacavirAntiretroviral therapyHIVNucleoside analogue reverse transcriptase inhibitor

Outcome Measures

Primary Outcomes (7)

  • Renal function measured by Cystatin-C and creatinine clearance

    Weeks 0, 4, 8, 12, 24, 24, 48, 96

  • Levels of renal tubule function markers in blood and urine

    Weeks 0, 12, 24, 48, 96

  • Bone mass assessed by DEXA

    Weeks 0, 24, 48, 96

  • Levels of bone turnover markers in blood and urine

    Weeks 0, 12, 24, 48, 96

  • Insulin resistance

    Weeks 0, 12, 24, 48, 96

  • Changes in body composition assessed by patient questionnaire and standardized examination by physician

    Weeks 0, 12, 24, 48, 96

  • Changes in subcutaneous adipose tissue assessed by DEXA

    Week 0, 24, 48, 96

Secondary Outcomes (5)

  • Patients with viral load < 40 copies/ml

    Weeks 0, 4, 8, 12, 24, 48, 96

  • CD-4 cell count

    Weeks 0, 4, 8, 12, 24, 48, 96

  • Fasting triglycerides, HDL and LDL

    Weeks 0, 12, 24, 48, 96

  • Development of resistance mutations

    Weeks 0, 12, 24, 48, 96

  • Development of adverse events and serious adverse events

    Weeks 0, 4, 8, 12, 24, 48, 96

Study Arms (2)

1

ACTIVE COMPARATOR

Tenofovir

Drug: Tenofovir disoproxil fumarate

2

ACTIVE COMPARATOR

Abacavir

Drug: Abacavir

Interventions

Tenofovir disoproxil fumarateDRUG

Tenofovir disoproxil 245 mg oral tablet once daily

1
AbacavirDRUG

Abacavir 300 mg oral tablet twice daily

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Århus N, 8200, Denmark

Location

Related Publications (2)

  • Rasmussen TA, Jensen D, Tolstrup M, Nielsen US, Erlandsen EJ, Birn H, Ostergaard L, Langdahl BL, Laursen AL. Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial. PLoS One. 2012;7(3):e32445. doi: 10.1371/journal.pone.0032445. Epub 2012 Mar 29.

    PMID: 22479327DERIVED

  • Rasmussen TA, Tolstrup M, Melchjorsen J, Frederiksen CA, Nielsen US, Langdahl BL, Ostergaard L, Laursen AL. Evaluation of cardiovascular biomarkers in HIV-infected patients switching to abacavir or tenofovir based therapy. BMC Infect Dis. 2011 Oct 4;11:267. doi: 10.1186/1471-2334-11-267.

    PMID: 21970555DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovirabacavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 20, 2010

Record last verified: 2010-12

Locations

DK(1)