Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318123
• Other study ID #: LAKE
• Secondary ID: 2004-001282-18
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2006
• Last updated: January 25, 2008
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2007
• Est. primary completion date: April 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. 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.

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:
• Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD

Locations

Country	Name	City	State
Italy	Institute of Infections and Tropical Diseases University of Brescia	Brescia
Spain	Hospital Generall de Alicante	Alicante	Alacant
Spain	Hospital Central de Asturias	Asturias	Oviedo
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Nuestra Sra del Rosell	Cartagena	Murcia
Spain	Hospital Arquitecto Marcide	Ferrol	A Coruña
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital de Granollers	Granollers	Barcelona
Spain	Hopsital Gregorio Marañón	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hopsital Costa del Sol	Marbella	Malaga
Spain	Hospital General de Murcia	Murcia
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife	Canarias
Spain	Hospital Clínico Universitario de Santiago	Santiago de Compostela	Galicia
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital de Tarragona	Tarragona
Spain	Hospital Universitari Dr. Peset	Valencia
Spain	Hospital Xeral de Vigo	Vigo	Pontevedra
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (2)

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

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the virological response over the 48 weeks of the study.		At 12, 24, 36 and 48 weeks	No
Secondary	To evaluate the immunological efficacy (changes in 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 impact of treatment on the lipid profile.		At 12, 24, 36 and 48 weeks	Yes
Secondary	To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 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
Secondary	To analyse the mutations that appear in patients that present virological failure.		When there is a virological failure.	No