Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily

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

Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

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

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

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. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
  4. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
  5. Subject able to follow the treatment period.
  6. Signature of the informed consent.
  7. 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:

  1. Hepatic tests > 5 times above normality.
  2. Pregnancy or breastfeeding
  3. Presence of opportunistic infections and/or recent tumours (< 6 months).
  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.

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 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
Drug: efavirenz
Efavirenz
Other Names:
  • sustiva
Drug: Abacavir+lamivudine
Abacavir+lamivudine
Other Names:
  • Kivexa
No Intervention: B
efavirenz + 2 NUCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load of HIV-1 at each visit with regard to the baseline visit.
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 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
At 12, 24, 36 and 48 weeks
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
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

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

November 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 12, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (Estimate)

April 14, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 25, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELA
  • 2004-001198-25

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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