Text Size

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
History of Changes
  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:

MedlinePlus related topics: Allergy HIV/AIDS
U.S. FDA Resources

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
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
Anti-HIV Agents
Antiviral Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013