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

Germans Trias i Pujol Hospital

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Kivexa

Study type: Interventional

Funder types: Other

Identifiers

NCT00318123

LAKE

2004-001282-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

A

Experimental group

Description:

Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD

Treatment:

Drug: Kivexa

B

Experimental group

Description:

Abacavir 600mg + lamivudine 300mg in ine tablet QD \* lopinavir/ritonavir 400/100 mg BID

Treatment:

Drug: Kivexa