Pharmacokinetic, pharmacogenetic aspects on drug-drug interactions between rifampicin and efavirenz

Karolinska institutet0 个研究点目标入组 0 人开始时间: 2009年3月11日最近更新: 2023年5月29日

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•Inclusion criteria for ARM-1
•-HIV-infected patients > 18 years of age
•-Active TB excluded
•-CD4 cell count <200/mm3 or total lymphocyte counts (TLCs) below 1200/ mm3 at the time of TB diagnosis
•-Naïve to antiretroviral therapy and TB treatment
•-Adequate venous access and willingness to allow blood samples to be used for the studies
•-Ability to give informed consent and willingness to comply with study requirements and procedures.
•-Females of child-bearing potential who are able and willing to either practice abstinence or use consistent non-hormonal forms of birth control (such as condoms, diaphragms, IUDs, etc.) while taking efavirenz
•Inclusion criteria for ARM-2
•-HIV-infected patients > 18 years of age and HAART to be initiated during TB treatment.
•-Newly diagnosed TB
•-CD4 cell count <200/mm3 or total lymphocyte counts (TLCs) below 1200/ mm3 at the time of TB diagnosis
•-Naïve to antiretroviral therapy and TB treatment
•-Adequate venous access and willingness to allow blood samples to be used for the studies
•-Ability to give informed consent and willingness to comply with study requirements and procedures.
•-A negative urine pregnancy test for females of child-bearing potential
•-Females of child-bearing potential who are able and willing to either practice abstinence or use of consistent non-hormonal forms of birth control (such as condoms, diaphragms, IUDs, etc.) while taking efavirenz

•Exclusion Criteria for ARM-1
•-Haemoglobin < 8 gm/dL
•-Presence of persistent diarrhoea or malabsorption that would interfere with the subject's ability to absorb drugs.
•-Drug or alcohol abuse that may impair safety or adherence or interfere with the study results.
•-Positive pregnancy test or breastfeeding female.
•-Severely ill patients with Karnofsky score of < 40%.or patients receiving other medications that may have drug interaction with efavirenz.
•-Prisoners
•-Unable to give informed consent
•-Previously exposed to ART
•-Base line serum aminotransferase level raised 3 folds and above.
•Exclusion Criteria for ARM-2
•-Haemoglobin < 8 gm/dL
•-Presence of persistent diarrhoea or malabsorption that would interfere with the subject's ability to absorb drugs.
•-Drug or alcohol abuse that may impair safety or adherence or interfere with the study results.
•-Positive pregnancy test or breastfeeding female.
•-Severely ill patients with Karnofsky score of < 40%.or patients receiving other medications that may have drug interaction with efavirenz.
•-Unable to give informed consent
•-Previously exposed to ART
•-Base line serum aminotransferase level raised 3 folds and above.
•-Prisoners

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