Optimization of tuberculosis and HIV co-treatment in Africa

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Tuberculosis

• Registration Number: PACTR2009040001261177
• Lead Sponsor: Karolinska institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 0

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.
-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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified