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Completed

NCT Number: NCT01044810

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

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).

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Key information

Conditions

Treatment Failure, HIV or AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections CD4 Cell Counts Communicable Diseases Exanthema Genital Diseases HIV Infections Hypersensitivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bamrasnaradura Infectious Disease Institute

Nonthaburi, 11000, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efavirenz-based regimens

Drug

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

Other names: Stocrin, Sustiva

Primary outcomes

  1. Time to Virological failure

    Time frame: until end of study cohort

    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 outcomes

  1. Virological suppression

    Time frame: 24 months

    Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml

  2. Median increase from baseline of CD4 cell count

    Time frame: 24 months

  3. Adverse events

    Time frame: until end of cohort

    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

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

    Time frame: until end of cohort

Sponsors and collaborators

Lead sponsor

Bamrasnaradura Infectious Diseases Institute

Other Gov

Collaborators

  • Clinical Research Collaborative Network
  • Thai Red Cross AIDS Research Centre

Registry information

Official study title

Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2010
Registry last updated
Mar 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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