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Comparison of two alternative combinations of nucleosides in HIV-1 infected patients with viral suppression on 3TC. Randomized, multicentre open trial.
ISRCTN ISRCTN61891868
DOI 10.1186/ISRCTN61891868
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of two alternative combinations of nucleosides in HIV-1 infected patients with viral suppression on 3TC. Randomized, multicentre open trial.
Scientific title
Acronym N/A
Serial number at source BICOMBO
Study hypothesis Compare virological response 48 weeks after switching the nucleoside analogue component.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Spain
Disease/condition/study domain Chronic human immunodeficiency virus (HIV) infection.
Participants - inclusion criteria 1. 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
Participants - exclusion criteria 1. 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
Anticipated start date 01/07/2005
Anticipated end date 30/06/2007
Status of trial Completed
Patient information material
Target number of participants 300
Interventions Switch nucleoside component of HAART to either Kivexa® or Truvada®.
Primary outcome measure(s) Proportion of patients with undetectable viral load at 48 weeks.
Secondary outcome measure(s) 1. 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
Sources of funding 1. Gilead Sciences
2. GlaxoSmithKline (GSK)
Trial website
Publications 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19398921
2. 2012 substudy results on body composition in http://www.ncbi.nlm.nih.gov/pubmed/22374987
Contact name Dr  Jose M  Gatell
  Address Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
Sponsor Sponsor not yet defined (Spain)
  Address Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
Date applied 09/09/2005
Last edited 07/09/2012
Date ISRCTN assigned 20/01/2006
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