Optimization of tuberculosis and HIV co-treatment in Africa

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2009040001261177
• Date of registration: 11/03/2009
• Primary sponsor: Karolinska institutet
• Public title: Optimization of tuberculosis and HIV co-treatment in Africa
• Scientific title: Pharmacokinetic, pharmacogenetic aspects on drug-drug interactions between rifampicin and efavirenz
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009040001261177
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Eleni Aklillu
• Affiliation: Division of Clinical pharmacology Department of Laboratory Medicine, Karolinska Institutet

• Name: Leif Bertilsson
• Affiliation: Division of Clinical pharmacology Department of Laboratory Medicine, Karolinska Institutet

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria for ARM-1
- HIV-infected patients b 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
- Na?ve 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 b 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
- Na?ve 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 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

Age minimum: 18 null
Age maximum: 65 null
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
Tuberculosis
null

Primary Outcome(s)

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 Outcome(s)

Efavirenz pharmacokinetic profile; proportion of patients with lower (`1 mg/l), normal therapeutic interval (1 to 4 mg/l) or higher (b4 mg/l) plasma efavirenz level in patients in Arm-1 and Arm-2.

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

Source(s) of Monetary Support

The European & Developing Countries Clinical Trials Partnership (EDCTP)