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

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