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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: efavirenz
* Drug: Abacavir+lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. HIV-1 infected patients. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months). Subject able to follow the treatment period. Signature of the informed consent. 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: Hepatic tests > 5 times above normality. Pregnancy or breastfeeding Presence of opportunistic infections and/or recent tumours (< 6 months). Suspected or documented resistance to any of the investigational drugs. Known allergic hypersensitivity to any of the investigational drugs or any similar drug. Subjects with abusive consumption of alcohol or illegal drugs. Patients participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h | Drug: efavirenz<br>* Efavirenz<br>* Other names: sustiva;Drug: Abacavir+lamivudine<br>* Abacavir+lamivudine<br>* Other names: Kivexa;|
| No Intervention: B<br>efavirenz + 2 NUCS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load of HIV-1 at each visit with regard to the baseline visit. |  | At 12, 24, 36 and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Antiviral efficacy, Tolerability, Immunologic response, Virologic response