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TuberculosisPhase 2TBHDTNCT02968927

TB Host Directed Therapy

A Phase 2 study testing Everolimus 0.5 MG, Auranofin 6 MG and Vitamin D3 in people with Tuberculosis, run by The Aurum Institute NPC at 1 site in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To examine the safety and preliminary efficacy of multiple adjunctive host directed TB therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent permanent lung damage. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis
What is being tested?
Everolimus 0.5 MG, Auranofin 6 MG and Vitamin D3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSouth Africa
Study dates
Nov 2016to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any trial-related procedures.
  • Aged 18 to 65 years, male, or if female, either not of reproductive potential (post-menopause, or status-post surgical sterilization) or with an intrauterine contraceptive device in place.
  • Body weight (in light clothing without shoes) between 40 and 90 kg.
  • First episode of pulmonary tuberculosis diagnosed by positive sputum AFB smear with subsequent culture confirmation OR positive Xpert TB/RIF with Ct <20 [4].
  • RIF susceptibility diagnosed by Xpert TB/RIF OR Hain test
  • Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis [5]
  • HIV-1 seronegative
  • HBsAg negative

Who cannot join

  • Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
  • Current or imminent treatment for malaria.
  • Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death during the trial or the follow-up period.
  • TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator.
  • History of allergy or hypersensitivity to any of the trial therapies or related substances, including known allergy or suspected hypersensitivity to rifampin or rifabutin.
  • Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
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  • Subjects with any of the following at screening:
  • Cardiac arrhythmia requiring medication;
  • Prolongation of QT/QTc interval with QTcF (Fridericia correction) >450 ms;
  • History of additional risk factors for Torsade de Pointes, (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
  • Any clinically significant ECG abnormality, in the opinion of the investigator.
  • Patients requiring concomitant medications that prolong the QT inter-val.
  • Random blood glucose >140 mg/dL, or history of unstable Diabetes Mellitus which required hospitalization for hyper- or hypoglycaemia within the past year prior to start of screening.
  • Use of systemic corticosteroids within the past 28 days.
  • Subjects with any of the following abnormal laboratory values:
  • creatinine >2 mg/dL
  • haemoglobin <8 g/dL
  • platelets <100x109 cells/L
  • serum potassium <3.5
  • aspartate aminotransferase (AST) ≥2.0 x ULN
  • alkaline phosphatase (AP) >5.0 x ULN
  • total bilirubin >1.5 mg/dL

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • The Aurum Institute: Tembisa Clinical Research Centre

    Tembisa, Gauteng, 1736

Other trials in South Africa

About this study

Official title: A Ph2 Randomized Trial to Evaluate the Safety Preliminary Efficacy and Biomarker Response of Host Directed Therapies Added to Rifabutin-modified Standard Therapy in Adults With Drug-Sensitive Smear-Positive Pulmonary TB

To examine the safety and preliminary efficacy of multiple adjunctive host directed TB therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent permanent lung damage.

Read the detailed description

OBJECTIVES:

To determine the safety and preliminary efficacy of 4 TB HDT candidates:

  1. Safety (treatment emergent serious adverse events and SUSARs)
  2. Microbiologic effects in sputum (culture conversion, change in MGIT TTP) and blood (WBA)
  3. PET/CT imaging
  4. Serum markers of inflammation
  5. Effects on Mtb-specific and general immune function
  6. Pulmonary effects (spirometry, 6MWT, O2 saturation, and St. George Respiratory Symptom Questionnaire) In each case, TB HDT effects will be determined by comparison to patients treated with standard TB therapy alone with regard to a common set of primary and secondary endpoints.

PRIMARY ENDPOINTS

  1. For auranofin, everolimus, and vitamin D: the proportions of patients experiencing suspected unexpected serious adverse reactions (SUSARs).
  2. For CC-11050: the proportion of patients experiencing treatment emergent serious adverse events (SAEs).
Conditions
Tuberculosis
Being tested
Everolimus 0.5 MG, Auranofin 6 MG, Vitamin D3, CC-11050, 2HRbZE/4HRb
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Everolimus 0.5 MGDrug

  • Auranofin 6 MGDrug

  • Vitamin D3Drug

  • CC-11050Drug

  • 2HRbZE/4HRbDrug

    Also called rifabutin-modified TB therapy

Study groups in NCT02968927
Study groupRoleWhat they receive
2HRbEZ/4HRbActive comparator2HRbZE
Receives: Drug: 2HRbZE/4HRb
EverolimusExperimentalEverolimus 0.5 MG
Receives: Drug: Everolimus 0.5 MG; Drug: 2HRbZE/4HRb
AuranofinExperimentalAuranofin 6 MG
Receives: Drug: Auranofin 6 MG; Drug: 2HRbZE/4HRb
Vitamin DExperimentalVitamin D3
Receives: Drug: Vitamin D3; Drug: 2HRbZE/4HRb
CC-11050ExperimentalCC-11050
Receives: Drug: CC-11050; Drug: 2HRbZE/4HRb

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAEs and SUSARs

    For auranofin, everolimus, and vitamin D: the proportions of patients experiencing suspected unexpected serious adverse reactions (SUSARs).

    For CC-11050: the proportion of patients experiencing treatment emergent serious adverse events (SAEs).

    Measured: through day 180

Secondary outcomes (2)

  1. TEAEs other than SAEs and SUSARs

    TEAEs other than SAEs, categorized according to severity, drug relatedness, and leading to early withdrawal.

    Measured: through day 180

  2. Sputum culture status on day 56

    Proportion of patients with positive sputum cultures on solid culture medium after 8 weeks of treatment

    Measured: day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionSep 2018
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02968927
Sponsor's protocol ID
TBHDT-AUR1-8-178
Acronym
TBHDT
Status last verified
Jan 2019
First submitted
8 Sep 2016
Last updated
10 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Wallis RS, Ginindza S, Beattie T, Arjun N, Likoti M, Edward VA, Rassool M, Ahmed K, Fielding K, Ahidjo BA, Vangu MDT, Churchyard G. Adjunctive host-directed therapies for pulmonary tuberculosis: a prospective, open-label, phase 2, randomised controlled trial. Lancet Respir Med. 2021 Aug;9(8):897-908. doi: 10.1016/S2213-2600(20)30448-3. Epub 2021 Mar 16.

    PubMed 33740465

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus 0.5 MG, Auranofin 6 MG and Vitamin D3 in people with Tuberculosis, run by The Aurum Institute NPC at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAEs and SUSARs (time frame: through day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02968927, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.

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