Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) Rifabutin Pharmacokinetics (PK) substudy

Not Applicable

Completed

• Conditions: Human immunodeficiency virus (HIV) / Tuberculosis (TB); Infections and Infestations; HIV disease resulting in tuberculosis

• Registration Number: ISRCTN13074752
• Lead Sponsor: MRC Clinical Trials Unit (UK)

Brief Summary

2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25014688 (added 16/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-03
• Study Completion: 2014-01-31
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. HIV-1 infected adults/adolescents (12 years and older) receiving boosted protease inhibitor (almost exclusively lopinavir/ritonavir, Aluvia) containing second-line ART within the EARNEST trial
2. Enrolled with or developing tuberculosis (TB) during EARNEST trial follow-up
3. Currently receiving or planning to initiate rifabutin-containing anti-TB treatment (ie no contraindications to rifabutin)
4. Who provide written informed consent

Exclusion Criteria

1. Patients who have already reached week 132 in the EARNEST trial at time of TB diagnosis will not be enrolled as practical considerations limit follow up to 12 weeks beyond the completion of the week 144 EARNEST visit.
2. Patients who have less than 10 weeks remaining in their course of TB treatment will not be enrolled as they will not contribute to the main PK evaluation at week 12 (window 10-14 weeks)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade 3/4 adverse events over the course of the trial and time to first event

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rifabutin and its 25-o-desacetyl metabolite pharmacokinetic parameters (from a population PK model)<br> 2. Lopinavir/ritonavir pharmacokinetic parameters (from a population PK model)<br> 3. Raltegravir pharmacokinetic parameters (from a population PK model)<br> 4. Response to TB therapy (culture positive at 24 weeks or subsequent relapse/recurrence)<br> 5. Rifamycin resistance<br>