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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314626
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : January 29, 2008
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: efavirenz Drug: Abacavir+lamivudine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: A
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
Drug: efavirenz
Other Name: sustiva

Drug: Abacavir+lamivudine
Other Name: Kivexa

No Intervention: B
efavirenz + 2 NUCS

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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314626

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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
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Principal Investigator: Bonaventura Clotet, MD, PhD Lluita contra la Sida Foundation-HIV Unit

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Responsible Party: LLuita Sida Foundation Identifier: NCT00314626    
Other Study ID Numbers: ELA
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: November 2007
Keywords provided by Germans Trias i Pujol Hospital:
Antiviral efficacy
Immunologic response
Virologic response
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers