Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BICOMBO
Study information
Scientific title
Acronym
Study hypothesis
Compare virological response 48 weeks after switching the nucleoside analogue component.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic human immunodeficiency virus (HIV) infection.
Intervention
Switch nucleoside component of HAART to either Kivexa® or Truvada®.
Intervention type
Drug
Phase
Not Specified
Drug names
abacavir/lamivudine (Kivexa®) , tenofovir/emtricitabine (Truvada®)
Primary outcome measure
Proportion of patients with undetectable viral load at 48 weeks.
Secondary outcome measures
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
Overall trial start date
01/07/2005
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/07/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Infectious Diseases and HIV Unit
Barcelona
08036
Spain
Funders
Funder type
Industry
Funder name
Gilead Sciences
Alternative name(s)
Gilead, Gilead Sciences, Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
GlaxoSmithKline (GSK)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Results
Martínez E, Arranz JA, Podzamczer D, Loncá M, Sanz J, Barragán P, Ribera E, Knobel H, Roca V, Gutiérrez F, Blanco JL, Mallolas J, Llibre JM, Clotet B, Dalmau D, Segura F, Arribas JR, Cosín J, Barrufet P, Casas E, Ferrer E, Curran A, González A, Pich J, Cruceta A, Arnaiz JA, Miró JM, Gatell JM, , A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in HIV-1-infected patients with virological suppression., J. Acquir. Immune Defic. Syndr., 2009, 51, 3, 290-297, doi: 10.1097/QAI.0b013e3181aa12d5.
-
Substudy results on body composition
Curran A, Martinez E, Podzamczer D, Lonca M, Barragan P, Crespo M, Falco V, Vidal-Sicart S, Imaz A, Martinez M, Gatell JM, Ribera E, Changes in body composition and mitochondrial DNA in HIV-1-infected patients switching to fixed-dose abacavir/lamivudine or tenofovir/emtricitabine: a substudy of the BICOMBO trial., Antivir. Ther. (Lond.), 2012, 17, 4, 711-718, doi: 10.3851/IMP2081.