Prospective, multi-center, one-arm pilot trial of Trizivir plus Tenofovir in adult HIV-infected antiretroviral-naive patients

ISRCTN ISRCTN19938041
DOI https://doi.org/10.1186/ISRCTN19938041
Secondary identifying numbers TTstudy-04
Submission date
14/09/2007
Registration date
25/09/2007
Last edited
23/10/2020
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 Daniel Podzamczer
Scientific

Infectious Disease Service
Hospital de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
Barcelona
08907
Spain

Email dpodzamczer@csub.scs.es

Study information

Study designProspective, multi-center, one-arm pilot trial.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleProspective, multi-center, one-arm pilot trial of Trizivir plus Tenofovir in adult HIV-infected antiretroviral-naive patients
Study acronymTT
Study objectivesA combination of trizivir plus tenofovir will be associated with a good efficacy and tolerability in antiretroviral naive patients, even in those with high baseline viral loads and low CD4 counts.
Ethics approval(s)1. Local ethical committee, approved on November 10, 2004
2. National Health Authorities (Agencia Española del Medicamento), approved on November 18, 2004
Health condition(s) or problem(s) studiedHIV infection
InterventionAll participants will initiate an antiretroviral regimen of Trizivir® (Active ingredients: zidovudine 300 mg + lamivudine 150 mg + abacavir 300 mg) 1 pill orally twice a day (bid) plus tenofovir 300 mg orally everyday (qd). The duration of the intervention is 2 years prolonged to a third if efficacy and tolerability are acceptable.
Intervention typeOther
Primary outcome measureViral load <50 copies/mL. Viral load is measured at baseline, week 2, 4, 12 and every 12 weeks thereafter up to the end of the study period.
Secondary outcome measures1. CD4 changes, measured at baseline, week 12 and every 12 weeks thereafter up to the end of the study period.
2. Adverse effects. Clinical signs related to adverse effects are evaluated every 3 months
3. Resistance mutations if virologic failure
4. Clinical progression, evaluated every 3 months
5. Adherence to therapy, evaluated every 3 months
Overall study start date13/12/2004
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Total final enrolment93
Key inclusion criteria1. Confirmed HIV infection
2. Age >= 18 years
3. AntiRetroViral (ARV) naive
4. CD4 > 100 cells/uL
5. Written informed consent
Key exclusion criteria1. Alanine aminotransferase >5 Upper Limit of Normal (ULN)
2. Hepatic cirrhosis
3. Renal insufficiency with creatinine clearance <50 ml/min
4. Haemoglobin (Hb) <9 g/dL
5. Neutrophils <1,000/uL
6. Platelets <30,000/uL
7. Pregnancy
8. Acute infection in the last two weeks
9. Systemic treatment for neoplasms
10. Hepatitis C Virus+ (HCV+) in patients who require treatment with interferon/ribavirin
Date of first enrolment13/12/2004
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Infectious Disease Service
Barcelona
08907
Spain

Sponsor information

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Research organisation

c/o Dr Asuncion Benito
Gran Via s/n Km 2,7 L'Hospitalet
Barcelona
08907
Spain

Email abenito@idibell.org
Website http://www.idibell.es
ROR logo "ROR" https://ror.org/0008xqs48

Funders

Funder type

Research organisation

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2008 23/10/2020 Yes No

Editorial Notes

23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.