Comparison of two alternative combinations of nucleosides in HIV-1 infected patients with viral suppression on 3TC. Randomized, multicentre open trial.
ISRCTN | ISRCTN61891868 |
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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
Scientific
Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
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 |
Completion date | 30/06/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Spain
Study participating centre
Infectious Diseases and HIV Unit
Barcelona
08036
Spain
08036
Spain
Sponsor information
Sponsor not yet defined (Spain)
Not defined
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)
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)
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |