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

Completed

• Conditions: Treatment Failure, HIV or AIDS; CD4 Cell Counts
• Interventions: Drug: Efavirenz-based regimens

• Registration Number: NCT01044810
• Lead Sponsor: Bamrasnaradura Infectious Diseases Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-14
• Last Update Posted: 2011-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 559

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simultaneous interruption (Exposure gr)	Efavirenz-based regimens	stopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens
Naive (Control group)	Efavirenz-based regimens	HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.
staggered interruption (exposure group)	Efavirenz-based regimens	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

Primary Outcome Measures

Name	Time	Method
Time to Virological failure	until end of study cohort	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

Secondary Outcome Measures

Name	Time	Method
Virological suppression	24 months	Virological suppression was defined as having plasma HIV-1 RNA \<50 copies/ml
Median increase from baseline of CD4 cell count	24 months
Adverse events	until end of cohort	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
Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events	until end of cohort

Trial Locations

Locations (1)

Bamrasnaradura Infectious Disease Institute; 🇹🇭 Nonthaburi, Thailand