Condition category
Infections and Infestations
Date applied
12/09/2005
Date assigned
19/01/2006
Last edited
24/07/2014
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 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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Trizivir (ABC), Lamivudine (3TC), Retrovir (AZT), Efavirenz (Sustiva), Lopinavir/ritonavir (Kaletra)

Primary outcome measures

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 trial start date

15/04/2003

Overall trial end date

31/12/2005

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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