Back to Search
Start Over
Plasma Concentrations, Efficacy and Safety of Efavirenz in HIV-Infected Adults Treated for Tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA Trial)
- Source :
- PLoS ONE, PLoS ONE, 2014, 9 (3), pp.e90350. ⟨10.1371/journal.pone.0090350⟩, PLoS ONE, Vol 9, Iss 3, p e90350 (2014), PLoS ONE, Public Library of Science, 2014, 9 (3), pp.e90350. ⟨10.1371/journal.pone.0090350⟩
- Publication Year :
- 2014
- Publisher :
- HAL CCSD, 2014.
-
Abstract
- ObjectiveTo assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients.MethodsHIV-infected adults with CD4+ T cell count ≤ 200/mm(3) received standard 6-month tuberculosis treatment and antiretroviral therapy including a daily-dose of 600 mg of efavirenz, irrespective of their body weight. Mid-dose blood samples were drawn both on tuberculosis treatment (week +2 and week +6 after antiretroviral therapy initiation, and week 22 of follow-up) and off tuberculosis treatment (week 50 of follow-up). Considered therapeutic range was 1,000 to 4,000 ng/mL. Multivariate analysis was performed to evaluate the association between efavirenz concentration below 1,000 ng/mL and virological failure. Linear regression was used to test the association between efavirenz exposure and CD4+ T cell gain. Severe side effects potentially related to efavirenz were described and their association with efavirenz exposure was tested by multivariate analysis.ResultsEfavirenz plasma concentrations were available in 540 patients. Median [interquartile range] efavirenz concentrations were 2,674 ng/mL [1,690-4,533], 2,667 ng/mL [1,753-4,494] and 2,799 ng/mL [1,804-4,744] at week +2, week +6, week 22, respectively, and 2,766 ng/mL [1,941-3,976] at week 50. Efavirenz concentrations were lower at week 50 (off rifampicin) compared to week 22 (on rifampicin) (pConclusionBody weight and tuberculosis treatment were not associated with low efavirenz concentrations or treatment failure, supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients. High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity.Trial registrationClinicalTrials.gov NCT01300481.
- Subjects :
- CD4-Positive T-Lymphocytes
Cyclopropanes
Male
Viral Diseases
HIV Infections
Pharmacology
chemistry.chemical_compound
0302 clinical medicine
Interquartile range
immune system diseases
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases
Blood plasma
Drug Interactions
030212 general & internal medicine
0303 health sciences
Multidisciplinary
Coinfection
Clinical Pharmacology
virus diseases
Antivirals
3. Good health
AIDS
Infectious Diseases
Alkynes
[SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases
Reverse Transcriptase Inhibitors
Medicine
Female
Cambodia
Research Article
medicine.drug
Adult
Drugs and Devices
Tuberculosis
Efavirenz
Clinical Research Design
Science
Sexually Transmitted Diseases
Microbiology
03 medical and health sciences
Adverse Reactions
Virology
medicine
Humans
Clinical Trials
Adverse effect
Biology
030306 microbiology
business.industry
Body Weight
HIV
medicine.disease
Benzoxazines
Pharmacodynamics
chemistry
[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
Hemoglobinemia
business
Rifampicin
Subjects
Details
- Language :
- English
- ISSN :
- 19326203
- Database :
- OpenAIRE
- Journal :
- PLoS ONE, PLoS ONE, 2014, 9 (3), pp.e90350. ⟨10.1371/journal.pone.0090350⟩, PLoS ONE, Vol 9, Iss 3, p e90350 (2014), PLoS ONE, Public Library of Science, 2014, 9 (3), pp.e90350. ⟨10.1371/journal.pone.0090350⟩
- Accession number :
- edsair.doi.dedup.....1b849cf5819d156ac04b64bafc5e1196