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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
efavirenz
Abacavir+lamivudine
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antiviral efficacy, Tolerability, Immunologic response, Virologic response, HIV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 years. HIV-1 infected patients. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months). Subject able to follow the treatment period. Signature of the informed consent. 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: Hepatic tests > 5 times above normality. Pregnancy or breastfeeding Presence of opportunistic infections and/or recent tumours (< 6 months). Suspected or documented resistance to any of the investigational drugs. Known allergic hypersensitivity to any of the investigational drugs or any similar drug. Subjects with abusive consumption of alcohol or illegal drugs. Patients participating in another clinical trial.

Sites / Locations

  • Germans Trias i Pujol Hospital
  • Hospital de Mataró
  • Hospital de Aranzazu
  • Hospital San Millan de Logroño
  • Hospital Principe de Asturias
  • Hospital de Móstoles
  • Hospital Costa del Sol
  • Hospital Universitario de Canarias
  • Hospital de la Vall d'Hebron
  • Hospital Virgen de las Nieves
  • Hospital Arnau de Vilanova de Lleida
  • Hospital Severo Ochoa Leganés
  • Hospital Cristal-Piñor
  • Hospital Santa María Nai
  • Hospital de Navarra
  • Hospital General de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h

efavirenz + 2 NUCS

Outcomes

Primary Outcome Measures

Viral load of HIV-1 at each visit with regard to the baseline visit.

Secondary Outcome Measures

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).

Full Information

First Posted
April 12, 2006
Last Updated
January 25, 2008
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
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1. Study Identification

Unique Protocol Identification Number
NCT00314626
Brief Title
Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
Official Title
Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antiviral efficacy, Tolerability, Immunologic response, Virologic response, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
Arm Title
B
Arm Type
No Intervention
Arm Description
efavirenz + 2 NUCS
Intervention Type
Drug
Intervention Name(s)
efavirenz
Other Intervention Name(s)
sustiva
Intervention Description
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Abacavir+lamivudine
Other Intervention Name(s)
Kivexa
Intervention Description
Abacavir+lamivudine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years. HIV-1 infected patients. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months). Subject able to follow the treatment period. Signature of the informed consent. 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: Hepatic tests > 5 times above normality. Pregnancy or breastfeeding Presence of opportunistic infections and/or recent tumours (< 6 months). Suspected or documented resistance to any of the investigational drugs. Known allergic hypersensitivity to any of the investigational drugs or any similar drug. Subjects with abusive consumption of alcohol or illegal drugs. Patients participating in another clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventura Clotet, MD, PhD
Organizational Affiliation
Lluita contra la Sida Foundation-HIV Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Mataró
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
Hospital de Aranzazu
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital San Millan de Logroño
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26001
Country
Spain
Facility Name
Hospital Principe de Asturias
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28005
Country
Spain
Facility Name
Hospital de Móstoles
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29600
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Arnau de Vilanova de Lleida
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Severo Ochoa Leganés
City
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital Cristal-Piñor
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital Santa María Nai
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

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

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