HIV/AIDS Tuberculosis
Conditions
Interventions
Arm-2: HIV and Tuberculosis infected
Arm-1:HIV but no Tuberculosis infected
Sponsors
Karolinska institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for ARM-1 - HIV-infected patients > 18 years of age - Active TB excluded - CD4 cell count 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
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of efavirenz based HAART as measured by plasma HIV-1 RNA load; proportion of patients with virologic success in patients in Arm-1 and Arm-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of efavirenz based HAART; incidence of mortality, type, frequency and severity of adverse events such as CNS toxicity, rash and drug induced hepatotoxicity etc between patients in Arm-1 and Arm-2;Efavirenz pharmacokinetic profile; proportion of patients with lower (4 mg/l) plasma efavirenz level in patients in Arm-1 and Arm-2. | — |
Countries
Ethiopia, Tanzania
Contacts
Public ContactLeif Bertilsson
Division of Clinical pharmacology Department of Laboratory Medicine, Karolinska Institutet
Outcome results
None listed