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

January 7, 2010
March 14, 2011
January 2010
March 2010   (final data collection date for primary outcome measure)
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
Virological failure 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 reveals NRTI or NNRTI resistance-associated mutations [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01044810 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Virological suppression defined as having plasma HIV-1 RNA <50 copies/ml [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • CD4 cell count change defined as change from baseline in absolute CD4 cell count [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
  • Adverse events of EFV-based regimens defined either (1) more than grade 3 according to DAID AE Grading Table, or (2) clinical events that leaded to changed antiretroviral medications [ Time Frame: 1-6 years ] [ Designated as safety issue: Yes ]
  • Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events [ Time Frame: 1-6 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Treatment Failure, HIV or AIDS
  • CD4 Cell Counts
Drug: Efavirenz-based regimens
Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
Other Name: Stocrin, Sustiva
  • 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
    Intervention: Drug: Efavirenz-based regimens
  • Naive (Control group)
    HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.
    Intervention: Drug: Efavirenz-based regimens
  • 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
    Intervention: Drug: Efavirenz-based regimens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
559
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01044810
BIDI-EFV
No
Krittaecho Siripassorn, Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
  • Thai Red Cross AIDS Research Centre
  • Clinical Research Collaborative Network
Principal Investigator: Krittaecho Siripassorn, MD Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP