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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314626
• Other study ID #: ELA
• Secondary ID: 2004-001198-25
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2006
• Last updated: January 25, 2008
• Start date: November 2004
• Est. completion date: March 2007

Study information

• Verified date: November 2007
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• efavirenz
Efavirenz
• Abacavir+lamivudine
Abacavir+lamivudine

Locations

Country	Name	City	State
Spain	Hospital Principe de Asturias	Alcala de Henares	Madrid
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona
Spain	Hospital de la Vall d'Hebron	Barcelona
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife
Spain	Hospital Arnau de Vilanova de Lleida	Lleida
Spain	Hospital San Millan de Logroño	Logroño	La Rioja
Spain	Hospital Severo Ochoa Leganés	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital de Mataró	Mataro	Barcelona
Spain	Hospital de Móstoles	Mostoles	Madrid
Spain	Hospital Cristal-Piñor	Ourense
Spain	Hospital Santa María Nai	Ourense
Spain	Hospital de Navarra	Pamplona
Spain	Hospital de Aranzazu	San Sebastian	Guipuzcoa
Spain	Hospital General de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load of HIV-1 at each visit with regard to the baseline visit.		At 12, 24, 36 and 48 weeks	No
Secondary	To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.		At 12, 24, 36 and 48 weeks	No
Secondary	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.		At 12, 24, 36 and 48 weeks	Yes
Secondary	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).		At 12, 24, 36 and 48 weeks	No