Comparison of two alternative combinations of nucleosides in HIV-1 infected patients with viral suppression on 3TC. Randomized, multicentre open trial.

ISRCTN ISRCTN61891868
DOI https://doi.org/10.1186/ISRCTN61891868
Secondary identifying numbers BICOMBO
Submission date
09/09/2005
Registration date
20/01/2006
Last edited
07/09/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jose M Gatell
Scientific

Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesCompare virological response 48 weeks after switching the nucleoside analogue component.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic human immunodeficiency virus (HIV) infection.
InterventionSwitch nucleoside component of HAART to either Kivexa® or Truvada®.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)abacavir/lamivudine (Kivexa®) , tenofovir/emtricitabine (Truvada®)
Primary outcome measureProportion of patients with undetectable viral load at 48 weeks.
Secondary outcome measures1. Time to virological failure
2. Incidence of clinical and laboratory adverse events leading to treatment discontinuation
3. Incidence of C events (CDC, 1993)
4. Change in CD4 from baseline
5. Change in triglyceride, cholesterol (total and high density lipoprotein [HDL] and low density lipoprotein [LDL])
6. Mutations of resistance in failing patients
Overall study start date01/07/2005
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. Male and female
2. HIV-1-infected
3. Age 18 and above
4. On stable highly active antiretroviral therapy (HAART), including lamivudine (3TC) for at least last 3 months
5. Plasma viral load <200 copies/ml for at least 4 months
6. Written informed consent
Key exclusion criteria1. Pregnancy, breastfeeding or intent to become pregnant during the study period
2. Active opportunistic infection requiring treatment by parenteral route
3. Creatinine (serum) >2 mg/dl
4. Current treatment with potentially nephrotoxic agents: aminoglicosides, amfotericin B, cidofovir, cisplatin, foscarnet, pentamidine IV
5. Treatment with adefovir, probenecid, interleukin-2, systemic steroids or investigational agents
6. Systemic antineoplastic chemotherapy
7. Any contraindication for study drugs
8. Prior failure on combinations including abacavir or tenofovir or with mutations of resistance to these drugs
Date of first enrolment01/07/2005
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • Spain

Study participating centre

Infectious Diseases and HIV Unit
Barcelona
08036
Spain

Sponsor information

Sponsor not yet defined (Spain)
Not defined

Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain

Funders

Funder type

Industry

Gilead Sciences
Government organisation / For-profit companies (industry)
Alternative name(s)
Gilead, Gilead Sciences, Inc.
Location
United States of America
GlaxoSmithKline (GSK)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2009 Yes No
Results article substudy results on body composition 01/07/2012 Yes No