Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients - Full Text View

Purpose

To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.

Condition	Intervention	Phase
HIV Infections	Drug: Kivexa	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 to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment

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:

To evaluate the virological response over the 48 weeks of the study. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the immunological efficacy (changes in 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 impact of treatment on the lipid profile. [ Time Frame: At 12, 24, 36 and 48 weeks ] [ Designated as safety issue: Yes ]
To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 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 ]
To analyse the mutations that appear in patients that present virological failure. [ Time Frame: When there is a virological failure. ] [ Designated as safety issue: No ]


Enrollment:	126
Study Start Date:	April 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD	Drug: Kivexa abacavir 600mg + lamivudine 300mg in one tablet QD
Experimental: B Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID	Drug: Kivexa abacavir 600mg + lamivudine 300mg in one tablet QD

Detailed Description:

The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.

Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.

It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.

The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.

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.
Naive to antiretroviral treatment.
Candidate patient for initiating antiretroviral treatment*.
Subject able to follow the treatment period.
Signature of the informed consent.
Women may not be fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use two contraceptive methods during the study, one of them at least being a barrier method.

Exclusion Criteria:

Hepatic tests > 5 times above normality.
Pregnancy or breastfeeding.
Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
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.
Terminal renal disease.

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: NCT00318123

Locations


Italy
Institute of Infections and Tropical Diseases University of Brescia
Brescia, Italy, 25125
Spain
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain, 15405
Hospital Generall de Alicante
Alicante, Alacant, Spain, 03010
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital de Granollers
Granollers, Barcelona, Spain, 08400
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canarias, Spain, 38320
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Hopsital Costa del Sol
Marbella, Malaga, Spain, 29600
Hospital Nuestra Sra del Rosell
Cartagena, Murcia, Spain, 30203
Hospital Central de Asturias
Asturias, Oviedo, Spain, 33006
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain, 36204
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hopsital Gregorio Marañón
Madrid, Spain, 28007
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital General de Murcia
Murcia, Spain, 30003
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital de Tarragona
Tarragona, Spain, 43007
Hospital Universitari Dr. Peset
Valencia, Spain, 46017
Hospital Miguel Servet
Zaragoza, Spain, 50009

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:	NCT00318123 History of Changes
Other Study ID Numbers:	LAKE 2004-001282-18
Study First Received:	April 25, 2006
Last Updated:	January 25, 2008
Health Authority:	Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:


Simplification therapy Efficacy Safety	Virological effectiveness Immunological effectiveness 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 Lamivudine Efavirenz Abacavir Dideoxynucleosides 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 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 Antimetabolites

ClinicalTrials.gov processed this record on September 27, 2016