Contact information
Type
Scientific
Contact name
Dr Jose Gatell
ORCID ID
Contact details
Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
+34 (0)932275430
gatell@medicina.ub.es
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
TRIZEFAL
Study information
Scientific title
Acronym
Study hypothesis
To assess the virological and immunological response in naive patients undergoing induction (24 weeks of intensive therapy with three nucleoside reverse transcriptase inhibitors [NRTIs] plus either a protease inhibitor or a non-nucleoside) followed by 48 weeks of maintenance therapy with three NRTIs.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus (HIV) infection
Intervention
Patients are randomly assigned to receive either:
1. Retrovir (AZT) + Lamivudine (3TC) + Trizivir (ABC) + Efavirenz (Sustiva), or
2. AZT + 3TC + ABC + Lopinavir/Ritonavir (Kaletra)
After 24 weeks, patients in both arms showing undetectable viral load will receive Trizivir for 48 more weeks.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Trizivir (ABC), Lamivudine (3TC), Retrovir (AZT), Efavirenz (Sustiva), Lopinavir/ritonavir (Kaletra)
Primary outcome measure
Proportion of patients with viral load below 20 copies/ml (polymerase chain reaction [PCR] estandar, Amplicor Monitor Roche Ultrasensible) at 72 weeks.
Secondary outcome measures
1. Proportion of patients with CD4+ cell count above 200 c/ml at 72 weeks
2. Proportion of patients with viral load <20 copies/ml at 24 weeks
3. Time to treatment failure
4. Duration of response
5. Incidence of adverse events (clinical and laboratory) leading to discontinuation of the study drugs
6. Incidence of C events (CDC 1993)
7. Death for any cause
Overall study start date
15/04/2003
Overall study end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female
2. HIV-1 infection
3. Age 18 or above
4. Antiretroviral-naive
5. Plasma viral load above 10,000 copies/ml
6. Life expectancy >72 weeks
7. Written informed consent
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
220
Participant exclusion criteria
1. Pregnancy, breastfeeding or intention to become pregnant during the study planned duration
2. Current opportunistic infection requiring parenteral therapy
3. Any formal contraindication to receive the study drugs
4. Current treatment with investigational drugs
Recruitment start date
15/04/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Spain
Study 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
+34 (0)932275430
gatell@medicina.ub.es
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (GSK)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|