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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Kivexa
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Simplification therapy, Efficacy, Safety, Virological effectiveness, Immunological effectiveness, HIV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Infections and Tropical Diseases University of Brescia
  • Hospital Arquitecto Marcide
  • Hospital Generall de Alicante
  • Hospital Universitari Germans Trias i Pujol
  • Hospital de Granollers
  • Hospital Universitario de Canarias
  • Hospital Clínico Universitario de Santiago
  • Hopsital Costa del Sol
  • Hospital Nuestra Sra del Rosell
  • Hospital Central de Asturias
  • Hospital Xeral de Vigo
  • Hospital Virgen de las Nieves
  • Hopsital Gregorio Marañón
  • Hospital 12 de Octubre
  • Hospital General de Murcia
  • Hospital Virgen Macarena
  • Hospital Virgen del Rocío
  • Hospital de Tarragona
  • Hospital Universitari Dr. Peset
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD

Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID

Outcomes

Primary Outcome Measures

To evaluate the virological response over the 48 weeks of the study.

Secondary Outcome Measures

To evaluate the immunological efficacy (changes in CD4 and CD8 counts) of the combination studied over the follow-up period.
To evaluate the impact of treatment on the lipid profile.
To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 48-week treatment period.
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).
To analyse the mutations that appear in patients that present virological failure.

Full Information

First Posted
April 25, 2006
Last Updated
January 25, 2008
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
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1. Study Identification

Unique Protocol Identification Number
NCT00318123
Brief Title
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Simplification therapy, Efficacy, Safety, Virological effectiveness, Immunological effectiveness, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD
Arm Title
B
Arm Type
Experimental
Arm Description
Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID
Intervention Type
Drug
Intervention Name(s)
Kivexa
Intervention Description
abacavir 600mg + lamivudine 300mg in one tablet QD
Primary Outcome Measure Information:
Title
To evaluate the virological response over the 48 weeks of the study.
Time Frame
At 12, 24, 36 and 48 weeks
Secondary Outcome Measure Information:
Title
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.
Title
To evaluate the impact of treatment on the lipid profile.
Time Frame
At 12, 24, 36 and 48 weeks
Title
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.
Title
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.
Title
To analyse the mutations that appear in patients that present virological failure.
Time Frame
When there is a virological failure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventura Clotet, MD, PhD
Organizational Affiliation
LLuita contra la Sida Foundation-HIV Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Infections and Tropical Diseases University of Brescia
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Hospital Arquitecto Marcide
City
Ferrol
State/Province
A Coruña
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Generall de Alicante
City
Alicante
State/Province
Alacant
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08400
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz de Tenerife
State/Province
Canarias
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hopsital Costa del Sol
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29600
Country
Spain
Facility Name
Hospital Nuestra Sra del Rosell
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30203
Country
Spain
Facility Name
Hospital Central de Asturias
City
Asturias
State/Province
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Xeral de Vigo
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hopsital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital General de Murcia
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital de Tarragona
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Hospital Universitari Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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