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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: efavirenz
Drug: Abacavir+lamivudine
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 of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: November 2004
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
Drug: efavirenz
Efavirenz
Other Name: sustiva
Drug: Abacavir+lamivudine
Abacavir+lamivudine
Other Name: Kivexa
No Intervention: B
efavirenz + 2 NUCS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00314626

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

No publications provided

Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00314626     History of Changes
Other Study ID Numbers: ELA, 2004-001198-25
Study First Received: April 12, 2006
Last Updated: January 25, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
Antiviral efficacy
Tolerability
Immunologic response
Virologic response
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Efavirenz
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 15, 2014