Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. staggered interruption; and (3) started EFV-based regimens as an initial regimen (as controlled group).

Official Title
-----------------
Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine

Conditions
-----------------
Treatment Failure, HIV or AIDS, CD4 Cell Counts

Intervention / Treatment
-----------------
* Drug: Efavirenz-based regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-70 years old documented HIV infection started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute Exclusion Criteria: previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients previously received protease inhibitor-based regimen diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simultaneous interruption (Exposure gr)<br>stopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens | Drug: Efavirenz-based regimens<br>* Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.<br>* Other names: Stocrin, Sustiva;|
| Naive (Control group)<br>HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens. | Drug: Efavirenz-based regimens<br>* Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.<br>* Other names: Stocrin, Sustiva;|
| staggered interruption (exposure group)<br>after having allergic reactions to NVP-based regimens, stopped NNRTIs first, continued the other NRTIs for a period of time, i.e. staggered interruption, and later started EFV-based regimens | Drug: Efavirenz-based regimens<br>* Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.<br>* Other names: Stocrin, Sustiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Virological failure | Virological failure was defined as either (1) two consecutive results of plasma HIV-1 RNA >400 copies/ml or (2) plasma HIV-1 RNA >1,000 copies/ml with genotypic resistance assay revealed NRTI or NNRTI resistance-associated mutations | until end of study cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological suppression | Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml | 24 months | 
| Median increase from baseline of CD4 cell count |  | 24 months | 
| Adverse events | Adverse events were defined as either (1) having more than grade 3 according to DAID AE Grading Table, or (2) having clinical events that leaded to changed antiretroviral medications | until end of cohort | 
| Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events |  | until end of cohort | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nevirapine, HIV, efavirenz, allergy, rash, Cohort Studies, Historical, Retrospective Study, exanthem, Antiretroviral Agents, Highly Active Antiretroviral Therapy, HAART, treatment failure