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
Protocol serial number	BICOMBO
Sponsor	Sponsor not yet defined (Spain)
Funders	Gilead Sciences, GlaxoSmithKline (GSK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jose M Gatell
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Compare 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) studied	Chronic human immunodeficiency virus (HIV) infection.
Intervention	Switch nucleoside component of HAART to either Kivexa® or Truvada®.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	abacavir/lamivudine (Kivexa®) , tenofovir/emtricitabine (Truvada®)
Primary outcome measure(s)	Proportion of patients with undetectable viral load at 48 weeks.
Key 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
Completion date	30/06/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key 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
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	30/06/2007

Infectious Diseases and HIV Unit

Barcelona
08036
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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