Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily - Full Text View

Sponsors and Collaborators:	Germans Trias i Pujol Hospital FUNDACIÓ LLUITA CONTRA LA SIDA
Information provided by:	Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:	NCT00314626

Purpose

To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.

Condition	Intervention	Phase
HIV Infections	Drug: efavirenz Drug: Abacavir+lamivudine	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine Abacavir Efavirenz Abacavir sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:

Viral load of HIV-1 at each visit with regard to the baseline visit. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 48-week treatment period. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: Yes ]
To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire). [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	November 2004
Study Completion Date:	March 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h	Drug: efavirenz Efavirenz Drug: Abacavir+lamivudine Abacavir+lamivudine
B: No Intervention efavirenz + 2 NUCS

Detailed Description:

Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.

The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years.
HIV-1 infected patients.
Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
Subject able to follow the treatment period.
Signature of the informed consent.
Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.

Exclusion Criteria:

Hepatic tests > 5 times above normality.
Pregnancy or breastfeeding
Presence of opportunistic infections and/or recent tumours (< 6 months).
Suspected or documented resistance to any of the investigational drugs.
Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
Subjects with abusive consumption of alcohol or illegal drugs.
Patients participating in another clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314626

Locations

Spain
Hospital de la Vall d'Hebron
Barcelona, Spain, 08035
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital Arnau de Vilanova de Lleida
Lleida, Spain, 25198
Hospital Severo Ochoa Leganés
Madrid, Spain, 28911
Hospital General de Valencia
Valencia, Spain, 46014
Hospital Cristal-Piñor
Ourense, Spain, 32005
Hospital de Navarra
Pamplona, Spain, 31008
Hospital Santa María Nai
Ourense, Spain, 32005
Spain, Barcelona
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Hospital de Mataró
Mataro, Barcelona, Spain, 08304
Spain, Guipuzcoa
Hospital de Aranzazu
San Sebastian, Guipuzcoa, Spain, 20014
Spain, La Rioja
Hospital San Millan de Logroño
Logroño, La Rioja, Spain, 26001
Spain, Málaga
Hospital Costa del Sol
Marbella, Málaga, Spain, 29600
Spain, Madrid
Hospital de Móstoles
Mostoles, Madrid, Spain, 28935
Hospital Principe de Asturias
Alcala de Henares, Madrid, Spain, 28005
Spain, Santa Cruz de Tenerife
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320

Sponsors and Collaborators

Germans Trias i Pujol Hospital

FUNDACIÓ LLUITA CONTRA LA SIDA

Investigators

Principal Investigator:

Bonaventura Clotet, MD, PhD

Lluita contra la Sida Foundation-HIV Unit

More Information

No publications provided

Responsible Party:	LLuita Sida Foundation ( LLuita Sida Foundation )
Study ID Numbers:	ELA, 2004-001198-25
Study First Received:	April 12, 2006
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00314626 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:

Antiviral efficacy
Tolerability
Immunologic response
Virologic response
HIV

Study placed in the following topic categories:

Efavirenz
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Lamivudine
Antiviral Agents
Immunologic Deficiency Syndromes

Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Abacavir
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009