Treatment Failure, HIV or AIDS, CD4 Cell Counts
Conditions
Keywords
HIV, efavirenz, nevirapine, allergy, rash, Cohort Studies, Historical, Retrospective Study, exanthem, Antiretroviral Agents, Highly Active Antiretroviral Therapy, HAART, treatment failure
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).
Interventions
Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
Sponsors
Thai Red Cross AIDS Research Centre
Clinical Research Collaborative Network
Bamrasnaradura Infectious Diseases Institute
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Virological failure | 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
| Measure | Time frame | Description |
|---|---|---|
| Virological suppression | 24 months | Virological suppression was defined as having plasma HIV-1 RNA \<50 copies/ml |
| Median increase from baseline of CD4 cell count | 24 months | — |
| Adverse events | 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 |
| Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events | until end of cohort | — |
Countries
Thailand
Outcome results
None listed