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NCT01044810
Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
trial testing Efavirenz-based regimens in Treatment Failure, HIV or AIDS in 559 participants. Completed in 1 March 2010.
1 March 2010
Quick facts
| Lead sponsor | Bamrasnaradura Infectious Diseases Institute |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 559 |
| Start date | 1 January 2010 |
| Primary completion | 1 March 2010 |
| Estimated completion | 1 March 2010 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Efavirenz-based regimens — full drug profile →
Conditions studied
- Treatment Failure, HIV or AIDS — all drugs for Treatment Failure, HIV or AIDS →
- CD4 Cell Counts — all drugs for CD4 Cell Counts →
Sponsor
Bamrasnaradura Infectious Diseases Institute
Who can join
Adults 18 to 70, any sex, with Treatment Failure, HIV or AIDS or CD4 Cell Counts. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01044810
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Efavirenz-based regimens
Trials testing the same drug.
- NCT01837277 — Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01044810 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bamrasnaradura Infectious Diseases Institute
- Last refreshed: 14 March 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01044810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing