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| Name | Class |
|---|---|
| Thai Red Cross AIDS Research Centre | OTHER |
| Clinical Research Collaborative Network | NETWORK |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Naive (Control group) | HIV-1-infected patients who started EFV-based regimens as their initial ARV 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz-based regimens | Drug | Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Virological suppression | Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml | 24 months |
| Median increase from baseline of CD4 cell count | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients who started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
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| Name | Affiliation | Role |
|---|---|---|
| Krittaecho Siripassorn, MD | Bamrasnaradura Infectious Diseases Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bamrasnaradura Infectious Disease Institute | Nonthaburi | 11000 | Thailand |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006967 | Hypersensitivity |
| D005076 | Exanthema |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
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| 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 |
| Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events | until end of cohort |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |