Condition category
Infections and Infestations
Date applied
14/09/2007
Date assigned
25/09/2007
Last edited
25/09/2007
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 Daniel Podzamczer

ORCID ID

Contact details

Infectious Disease Service
Hospital de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
Barcelona
08907
Spain
dpodzamczer@csub.scs.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TTstudy-04

Study information

Scientific title

Acronym

TT

Study hypothesis

A 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

1. Local ethical committee, approved on November 10, 2004
2. National Health Authorities (Agencia Española del Medicamento), approved on November 18, 2004

Study design

Prospective, multi-center, one-arm pilot trial.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV infection

Intervention

All 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Viral 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 measures

1. 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 trial start date

13/12/2004

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed HIV infection
2. Age >= 18 years
3. AntiRetroViral (ARV) naive
4. CD4 > 100 cells/uL
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. 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

Recruitment start date

13/12/2004

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Infectious Disease Service
Barcelona
08907
Spain

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.idibell.es

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes