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

HIV Infections Clinical Trial

— OPTI-NNRTI  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523458
• Other study ID #: Stanford Protocol ID: 95564
• Status: Terminated
• Phase: Phase 4
• First received: August 29, 2007
• Last updated: July 20, 2011
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Drug:
• efavirenz or nevirapine
Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.

Locations

Country	Name	City	State
Brazil	Hospital Universitario Prof. Edgard Santos/Universidade Federal da Bahia	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decline in HIV RNA in plasma Rise in CD4 cell count	These laboratory measures would be used to determine if there was a difference in the ARV failure rate between patients receiving standard dose vs high dose treatment with NNRTIs	Baseline, and Weeks 8, 20 and 32	No