Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: African Poverty Related Infection Oriented Research Initiative
• Collaborators: Kilimanjaro Christian Medical Centre, Tanzania; Radboud University
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• A smear-positive pulmonary tuberculosis, based on positive smear of at least two sputum samples with Ziehl-Neelsen (ZN) staining.

• HIV-infected as documented by positive HIV antibody test.

• Subject is at least 18 years of age at the day of the first dosing of study medication.

• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

• CD4 cell count > 50 copies/mm3.

• Karnofsky score > 40.

• Willing and able to regularly attend the Kibung'oto National Tuberculosis Hospital (KNTH) clinic.

Exclusion Criteria:

• History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.

• Previously treated for HIV infection with antiretroviral agents.

• Pregnant or breastfeeding.

• Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

• A history of severe psychiatric disease such as psychosis, schizophrenia, etc.

• Inability to understand the nature and extent of the trial and the procedures required.

• Abnormal serum transaminases or creatinine, determined as levels being > 5 times upper limit of normal.

• Active hepatobiliary or hepatic disease (Non B Chronic Hepatitis B/C co-infection is allowed).

• CD4 cell count > 350 cells/mm3.