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

B

Bamrasnaradura Infectious Diseases Institute

Status

Completed

Conditions

CD4 Cell Counts
Treatment Failure, HIV or AIDS

Treatments

Drug: Efavirenz-based regimens

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT01044810
BIDI-EFV

Details and patient eligibility

About

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).

Enrollment

559 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

559 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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