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

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

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).

Study Overview

• Status: Completed
• Conditions: Treatment Failure, HIV or AIDS; CD4 Cell Counts
• Intervention / Treatment: Drug: Efavirenz-based regimens

• Study Type: Observational
• Enrollment (Actual): 559

Contacts and Locations

Study Locations

• Thailand
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Infectious Disease Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients who started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Simultaneous interruption (Exposure gr); 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; Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.; Other Names: Stocrin, Sustiva
Naive (Control group); HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.	Drug: Efavirenz-based regimens; Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.; Other Names: Stocrin, Sustiva
staggered interruption (exposure group); 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; Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.; 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

Collaborators and Investigators

• Sponsor: Bamrasnaradura Infectious Diseases Institute
• Collaborators: Thai Red Cross AIDS Research Centre; Clinical Research Collaborative Network

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 7, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 8, 2010

Study Record Updates

• Last Update Posted (Estimate): March 15, 2011
• Last Update Submitted That Met QC Criteria: March 14, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: HIV; treatment failure; efavirenz; HAART; allergy; nevirapine; rash; Retrospective Study; Highly Active Antiretroviral Therapy; Antiretroviral Agents; Cohort Studies, Historical; exanthem
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Efavirenz
• Other Study ID Numbers: BIDI-EFV