Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
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 study start date
01/07/2005
Overall study 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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
GlaxoSmithKline (GSK)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |