Evaluation of two Trizivir-based strategies of induction-maintenance in antiretroviral-naive HIV-infected patients

ISRCTN	ISRCTN41611080
DOI	https://doi.org/10.1186/ISRCTN41611080
Protocol serial number	TRIZEFAL
Sponsor	Sponsor not yet defined (Spain)
Funder	GlaxoSmithKline (GSK)

Submission date: 12/09/2005
Registration date: 19/01/2006
Last edited: 24/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jose Gatell
Scientific

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

Phone	+34 (0)932275430
Email	gatell@medicina.ub.es

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Trizivir (ABC), Lamivudine (3TC), Retrovir (AZT), Efavirenz (Sustiva), Lopinavir/ritonavir (Kaletra)
Primary outcome measure(s)	Proportion of patients with viral load below 20 copies/ml (polymerase chain reaction [PCR] estandar, Amplicor Monitor Roche Ultrasensible) at 72 weeks.
Key secondary outcome measure(s)	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
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	220
Key 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
Key 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
Date of first enrolment	15/04/2003
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Spain

Study participating centre

Infectious Diseases and HIV Unit

Barcelona
08036
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan