PACTR2009040001261177
Recruiting
未知
Pharmacokinetic, pharmacogenetic aspects on drug-drug interactions between rifampicin and efavirenz
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Karolinska institutet
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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