CD4 Cell Counts Clinical Trial
Official title:
Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
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).
| Status | Completed |
| Enrollment | 559 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Bamrasnaradura Infectious Disease Institute | Nonthaburi |
| Lead Sponsor | Collaborator |
|---|---|
| Bamrasnaradura Infectious Diseases Institute | Clinical Research Collaborative Network, Thai Red Cross AIDS Research Centre |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Virological suppression | Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml | 24 months | No |
| Secondary | Median increase from baseline of CD4 cell count | 24 months | No | |
| Secondary | Adverse events | 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 | until end of cohort | Yes |
| Secondary | Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events | until end of cohort | No |