Clinical trial NCT00318123: Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
Official title: Multicentre, Open Label, Prospective, Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Simplification therapy
Efficacy
Safety
Virological effectiveness
Immunological effectiveness
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: 2006-04-26
Enrollment: 126
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 therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.

Detailed description: The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.

Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.

It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.

The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.

Eligibility criteria: Inclusion Criteria:

1. Age\> 18 years.
2. HIV-1 infected patients.
3. Naive to antiretroviral treatment.
4. Candidate patient for initiating antiretroviral treatment\*.
5. Subject able to follow the treatment period.
6. Signature of the informed consent.
7. Women may not be fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use two contraceptive methods during the study, one of them at least being a barrier method.

Exclusion Criteria:

1. Hepatic tests \> 5 times above normality.
2. Pregnancy or breastfeeding.
3. Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
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.
8. Terminal renal disease.

Primary outcomes:
measure: To evaluate the virological response over the 48 weeks of the study.
timeFrame: At 12, 24, 36 and 48 weeks
Secondary outcomes:
measure: To evaluate the immunological efficacy (changes in 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 impact of treatment on the lipid profile.
timeFrame: At 12, 24, 36 and 48 weeks
measure: To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 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.
measure: To analyse the mutations that appear in patients that present virological failure.
timeFrame: When there is a virological failure.
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Institute of Infections and Tropical Diseases University of Brescia
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: A Coruña
city: Alicante
country: Spain
facility: Hospital Generall de Alicante
state: Alacant
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital de Granollers
state: Barcelona
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: Galicia
city: Marbella
country: Spain
facility: Hopsital Costa del Sol
state: Malaga
city: Cartagena
country: Spain
facility: Hospital Nuestra Sra del Rosell
state: Murcia
city: Asturias
country: Spain
facility: Hospital Central de Asturias
state: Oviedo
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
state: Pontevedra
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hopsital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Murcia
country: Spain
facility: Hospital General de Murcia
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital de Tarragona
city: Valencia
country: Spain
facility: Hospital Universitari Dr. Peset
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: LLuita contra la Sida Foundation-HIV Unit
name: Bonaventura Clotet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: