Condition category
Infections and Infestations
Date applied
09/09/2005
Date assigned
20/01/2006
Last edited
07/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose M Gatell

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Sponsor not yet defined (Spain)

Sponsor details

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

Sponsor type

Not defined

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes