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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Abacavir Efavirenz Abacavir sulfate

U.S. FDA Resources

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
Experimental: A abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h	Drug: efavirenz Efavirenz Other Name: sustiva Drug: Abacavir+lamivudine Abacavir+lamivudine Other Name: Kivexa
No Intervention: B 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Hospital de Mataró
Mataro, Barcelona, Spain, 08304
Hospital de Aranzazu
San Sebastian, Guipuzcoa, Spain, 20014
Hospital San Millan de Logroño
Logroño, La Rioja, Spain, 26001
Hospital Principe de Asturias
Alcala de Henares, Madrid, Spain, 28005
Hospital de Móstoles
Mostoles, Madrid, Spain, 28935
Hospital Costa del Sol
Marbella, Málaga, Spain, 29600
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320
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 Cristal-Piñor
Ourense, Spain, 32005
Hospital Santa María Nai
Ourense, Spain, 32005
Hospital de Navarra
Pamplona, Spain, 31008
Hospital General de Valencia
Valencia, Spain, 46014

Sponsors and Collaborators

Germans Trias i Pujol Hospital

Fundacio Lluita Contra la SIDA

Investigators


Principal Investigator:	Bonaventura Clotet, MD, PhD	Lluita contra la Sida Foundation-HIV Unit

More Information


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

Keywords provided by Germans Trias i Pujol Hospital:


Antiviral efficacy Tolerability Immunologic response Virologic response HIV

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Abacavir Dideoxynucleosides Lamivudine Efavirenz Reverse Transcriptase Inhibitors	Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on September 26, 2016