Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

Study Overview
=================
Brief Summary
-----------------
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.

Detailed Description
-----------------
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence. The trial is prolonged for a total of 48 weeks.

Official Title
-----------------
Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: emtricitabine, FTC (drug)
* Drug: didanosine, ddI (drug)
* Drug: efavirenz (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected adults Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors CD4 cell count over 100/mm3 HIV RNA below 400 copies/ml since 6 months Signed written informed consent Exclusion Criteria: Previous treatment with non nucleoside analogue, ddI alone Pregnancy Alcool abuse Acute infection, past neurological or pancreatic disease, biological abnormalities Chemotherapy or immunotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: emtricitabine, FTC (drug)|nan|
|Drug: didanosine, ddI (drug)|nan|
|Drug: efavirenz (drug)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological success from W0 to W48 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of HIV infection |  |  | 
| CD4 cell count |  |  | 
| Safety |  |  | 
| Treatment adherence |  |  | 
| Quality of life |  |  | 
| Viral mutations |  |  | 
| Therapeutic strategy failure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infections, Reverse Transcriptase Inhibitors, Treatment simplification