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

This study has been completed.
Sponsor:
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00314626
First received: April 12, 2006
Last updated: January 25, 2008
Last verified: November 2007

April 12, 2006
January 25, 2008
November 2004
February 2007   (final data collection date for primary outcome measure)
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 ]
Viral load of HIV-1 at each visit with regard to the baseline visit.
Complete list of historical versions of study NCT00314626 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.
  • 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.
  • 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).
Not Provided
Not Provided
 
Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: efavirenz
    Efavirenz
    Other Name: sustiva
  • Drug: Abacavir+lamivudine
    Abacavir+lamivudine
    Other Name: Kivexa
  • Experimental: A
    abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
    Interventions:
    • Drug: efavirenz
    • Drug: Abacavir+lamivudine
  • No Intervention: B
    efavirenz + 2 NUCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
March 2007
February 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00314626
ELA, 2004-001198-25
No
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Bonaventura Clotet, MD, PhD Lluita contra la Sida Foundation-HIV Unit
Germans Trias i Pujol Hospital
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP