A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Efavirenz; Nevirapine

Criteria

Inclusion Criteria:

• ARV naïve subjects

• Documented HIV infection

• Documented TB infection

• Platelet count 40,000/mm3

• Hemoglobin ≥8.0 g/dL

• Absolute neutrophil count (ANC) >500/mm3

• AST (SGOT), ALT (SGPT), and alkaline phosphatase <3 X ULN

• Total bilirubin <2.5 x ULN

• Calculated creatinine clearance ≥60 mL/min

• For women of reproductive potential, negative urine pregnancy test

Exclusion Criteria:

• Unable to provide informed consent.

• History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.

• Patients on hemodialysis.

• Tuberculosis meningitis.

• Women with CD4 > 250 and men with CD4 > 400 due to higher risk of hepatotoxicity related to use of NVP.

• Positive serology for hepatitis C.

• Evidence for active hepatitis B including positive serologies for HBsAg, HBeAg, or HBV-DNA. Note: If anti-HBs is positive, patient is eligible for study if liver enzymes are within the parameters indicated in the inclusion criteria

• Women who are breast-feeding

• Known allergy/sensitivity to study drug(s) or their formulations

• Patients with other OIs or intercurrent illness that could affect their ability to take study drugs