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

This study has been completed.
Sponsor:
Collaborators:
Thai Red Cross AIDS Research Centre
Clinical Research Collaborative Network
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT01044810
First received: January 7, 2010
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention
Treatment Failure, HIV or AIDS
CD4 Cell Counts
Drug: Efavirenz-based regimens

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine

Resource links provided by NLM:


Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

Primary Outcome Measures:
  • Time to Virological failure [ Time Frame: until end of study cohort ] [ Designated as safety issue: No ]
    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:
  • Virological suppression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml

  • Median increase from baseline of CD4 cell count [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: until end of cohort ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: until end of cohort ] [ Designated as safety issue: No ]

Enrollment: 559
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: Stocrin, Sustiva

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044810

Locations
Thailand
Bamrasnaradura Infectious Disease Institute
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Thai Red Cross AIDS Research Centre
Clinical Research Collaborative Network
Investigators
Principal Investigator: Krittaecho Siripassorn, MD Bamrasnaradura Infectious Diseases Institute
  More Information

No publications provided

Responsible Party: Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier: NCT01044810     History of Changes
Other Study ID Numbers: BIDI-EFV
Study First Received: January 7, 2010
Last Updated: March 14, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Bamrasnaradura Infectious Diseases Institute:
HIV
efavirenz
nevirapine
allergy
rash
Cohort Studies, Historical
Retrospective Study
exanthem
Antiretroviral Agents
Highly Active Antiretroviral Therapy
HAART
treatment failure

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Nevirapine
Efavirenz
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 01, 2014