Clinical trial NCT00314626: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Antiviral efficacy
Tolerability
Immunologic response
Virologic response
HIV
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2006-04-14
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Viral load of HIV-1 at each visit with regard to the baseline visit.
timeFrame: At 12, 24, 36 and 48 weeks
Secondary outcomes:
measure: To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.
timeFrame: At 12, 24, 36 and 48 weeks
measure: 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.
timeFrame: At 12, 24, 36 and 48 weeks
measure: 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).
timeFrame: At 12, 24, 36 and 48 weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
city: Mataro
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital de Aranzazu
state: Guipuzcoa
city: Logroño
country: Spain
facility: Hospital San Millan de Logroño
state: La Rioja
city: Alcala de Henares
country: Spain
facility: Hospital Principe de Asturias
state: Madrid
city: Mostoles
country: Spain
facility: Hospital de Móstoles
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Barcelona
country: Spain
facility: Hospital de la Vall d'Hebron
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital Severo Ochoa Leganés
city: Ourense
country: Spain
facility: Hospital Cristal-Piñor
city: Ourense
country: Spain
facility: Hospital Santa María Nai
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Valencia
country: Spain
facility: Hospital General de Valencia
Study officials:
affiliation: Lluita contra la Sida Foundation-HIV Unit
name: Bonaventura Clotet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: