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Non-nucleoside Reverse Transcriptase Inhibitor

Rifabutin + Isoniazid +/- Efavirenz for HIV-Related Tuberculosis

N/A

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be willing to begin an antiretrovial regimen containing efavirenz and two NRTIs (combinations defined by protocol) at the requisite dosing

Eligible subjects enrolled in Study 23 or HIV-infected patients with culture confirmed or suspected tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying the best way to give rifabutin and isoniazid to people with both HIV and tuberculosis (TB) infection. Researchers want to see if giving rifabutin twice a week and adding efavirenz to the regimen is better than giving rifabutin 300 mg twice a week without efavirenz.

Who is the study for?

This trial is for HIV-infected patients with confirmed or suspected tuberculosis, currently on TB therapy but not antiretroviral therapy. They must be willing to start a regimen including efavirenz and two NRTIs. Excluded are pregnant or breastfeeding women, those with low hematocrit levels, prior NNRTI use, protease inhibitor use, and certain other medications.Check my eligibility

What is being tested?

The study compares the effects of rifabutin (600 mg twice weekly) combined with efavirenz (600 mg daily) versus rifabutin alone (300 mg twice weekly). It aims to understand how these drugs interact in the body and their impact on neutrophil count as well as develop models for optimal dosing times.See study design

What are the potential side effects?

Potential side effects may include changes in blood counts like neutropenia due to rifabutin's effect on white blood cells. Efavirenz could cause nervous system symptoms such as dizziness or trouble sleeping, rash, and increased liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to start a specific HIV treatment as outlined by the study.

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I am part of Study 23 or I have HIV with confirmed or suspected tuberculosis.

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I am currently on tuberculosis treatment but not on HIV medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,402 Total Patients Enrolled

38 Trials studying Tuberculosis

72,378 Patients Enrolled for Tuberculosis

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

317,016 Total Patients Enrolled

4 Trials studying Tuberculosis

141 Patients Enrolled for Tuberculosis

Media Library

Efavirenz (Non-nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00018083 — N/A

Tuberculosis Clinical Trial 2023: Efavirenz Highlights & Side Effects. Trial Name: NCT00018083 — N/A

Efavirenz (Non-nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00018083 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this study at least eighteen years of age?

"This medical trial is open to individuals who are of legal age and below the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

2024. "Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00018083.

All > Tuberculosis > Ic

~233 spots leftby Apr 2025

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