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

January 25, 2008 updated by: Germans Trias i Pujol Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age> 18 years.
  2. HIV-1 infected patients.
  3. Naive to antiretroviral treatment.
  4. Candidate patient for initiating antiretroviral treatment*.
  5. Subject able to follow the treatment period.
  6. Signature of the informed consent.
  7. 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:

  1. Hepatic tests > 5 times above normality.
  2. Pregnancy or breastfeeding.
  3. Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
  4. Suspected or documented resistance to any of the investigational drugs.
  5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
  6. Subjects with abusive consumption of alcohol or illegal drugs.
  7. Patients participating in another clinical trial.
  8. Terminal renal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the virological response over the 48 weeks of the study.
Time Frame: At 12, 24, 36 and 48 weeks
At 12, 24, 36 and 48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
At 12, 24, 36 and 48 weeks.
To evaluate the impact of treatment on the lipid profile.
Time Frame: At 12, 24, 36 and 48 weeks
At 12, 24, 36 and 48 weeks
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.
At 12, 24, 36 and 48 weeks.
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.
At 12, 24, 36 and 48 weeks.
To analyse the mutations that appear in patients that present virological failure.
Time Frame: When there is a virological failure.
When there is a virological failure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 25, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimate)

April 26, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 25, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAKE
  • 2004-001282-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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