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

NCT01044810 | Completed

• 1 other identifier: BIDI-EFV
• Study Type: observational
• Target: 559
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Treatment Failure, HIV or AIDS; CD4 Cell Counts

Keywords

HIV; efavirenz; nevirapine; allergy; rash; Cohort Studies, Historical; Retrospective Study; exanthem; Antiretroviral Agents; Highly Active Antiretroviral Therapy; HAART; treatment failure

Outcome Measures

Primary Outcomes (1)

• Time to Virological failure

  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

  until end of study cohort

Secondary Outcomes (4)

• Virological suppression

  24 months

• Median increase from baseline of CD4 cell count

  24 months

• Adverse events

  until end of cohort

• Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events

  until end of cohort

Study Arms (3)

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

Naive (Control group)

HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.

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

Drug: Efavirenz-based regimens

Interventions

Efavirenz-based regimens DRUG

Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.

Also known as: Stocrin, Sustiva

Naive (Control group); Simultaneous interruption (Exposure gr); staggered interruption (exposure group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age 18-70 years old
• documented HIV infection
• started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute

You may not qualify if:

• 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

Sponsors & Collaborators

• Bamrasnaradura Infectious Diseases Institute: lead
• Thai Red Cross AIDS Research Centre: collaborator
• Clinical Research Collaborative Network: collaborator

Study Sites (1)

Bamrasnaradura Infectious Disease Institute

Nonthaburi, 11000, Thailand

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hypersensitivity; Exanthema

Interventions

efavirenz

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Krittaecho Siripassorn, MD

  Bamrasnaradura Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2011-03

Locations

TH (1)