Human immunodeficiency virus (HIV) / Tuberculosis (TB) Infections and Infestations HIV disease resulting in tuberculosis
Conditions
Interventions
Patients will be randomised in a ratio of 1:1 to the following two treatment groups:
Group 1: rifabutin (150 mg) three times a week (Monday/Wednesday/Friday)
Group 2: r
Sponsors
MRC Clinical Trials Unit (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 3/4 adverse events over the course of the trial and time to first event | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rifabutin and its 25-o-desacetyl metabolite pharmacokinetic parameters (from a population PK model) 2. Lopinavir/ritonavir pharmacokinetic parameters (from a population PK model) 3. Raltegravir pharmacokinetic parameters (from a population PK model) 4. Response to TB therapy (culture positive at 24 weeks or subsequent relapse/recurrence) 5. Rifamycin resistance | — |
Countries
Uganda
Outcome results
None listed