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
Prospective, multi-center, one-arm pilot trial of Trizivir plus Tenofovir in adult HIV-infected antiretroviral-naive patients
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 measure
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 (if study stopped)
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
Total final enrolment
93
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
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
Basic results (scientific)
Publication list
2008 results in https://pubmed.ncbi.nlm.nih.gov/18671476/ (added 23/10/2020)