TuberculosisTRuTHNCT01539005
Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy
An observational study of Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
Trial summary
This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly active antiretroviral therapy (HAART).The primary objective of this study is to determine the incidence of TB recurrence in patients on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 402 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2009to 23 Apr 2014
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women > 18 years of age with documented HIV infection and past TB therapy as part of the SAPIT and START trial will be enrolled.
Who may be able to join
- Adult patients (> 18 years) who were diagnosed as co-infected with TB and HIV and previously enrolled in the SAPIT and START trials
- Willing to consent to participate in this study and contribute specimens to the K-RITH repository for future investigations
Who cannot join
- Patients with Extensively drug-resistant (XDR) TB will not be eligible.
- Patients who refuse consent
Trial locations and contacts
1 site in 1 country.
South Africa1 site
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, 4001
About this study
Official title: Is Tuberculosis Recurrence in Treated Tuberculosis-Human Immunodeficiency Virus (HIV) Co-Infected Patients Relapse or Re-infection?
This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly active antiretroviral therapy (HAART).The primary objective of this study is to determine the incidence of TB recurrence in patients on HAART.The study is being conducted at the CAPRISA eThekwini Clinical Research Site (CRS), which is adjacent to the Prince Cyril Zulu Communicable Disease Clinic (PCZCDC), a major urban TB clinic, in Durban, South Africa.No hypotheses will be tested in this study; however, the primary study question will determine the proportion of TB recurrence due to relapse vs. re-infection.The study has enrolled 402 participants
Read the detailed description
- Objective: To determine the extent of and reasons for relapse and re-infection in incident cases of tuberculosis (TB) in Human Immunodeficiency Virus (HIV)-infected patients on Highly Active Antiretroviral Therapy (HAART)
- Design: A prospective cohort study of patients with HIV previously treated for pulmonary TB and initiated on HAART in the SAPIT (Starting AIDS treatment at three Points in TB treatment) and START (Starting Tuberculosis and Anti-Retroviral Therapy) trials. Each incident case of TB recurrence in this cohort of adult patients on HAART will be investigated to assess whether the infecting mycobacterium is similar to that from the previous infection and whether the immune responses differ in cases of relapse and re-infection.
- Population: Men and women 18 years of age with documented HIV infection and past TB therapy as part of the SAPIT and START trial will be enrolled.
- Study Procedures: This study will involve 3 years of follow-up of patients who had been initiated on a course of TB therapy as part of the SAPIT and START trials. Upon exit from the SAPIT trial (i.e. 18 months post-TB diagnosis), study patients will be consented and enrolled in this cohort study. Study participants will be seen monthly for the first 3 months and thereafter 3 monthly, for routine clinic visits and ART services. At every visit patients will be screened for TB recurrence clinically, with chest radiograph and, whenever possible, with available TB diagnostics or new diagnostics that are being developed and/or tested.
- Study Outcome The primary endpoint of this study will be the development of recurrent TB. TB recurrence as a result of relapse will be defined as isolates of M. tuberculosis from the first and second episodes of TB which cluster in Restriction Fragment Length Polymerization (RFLP) analysis. TB recurrence as a result of re-infection will be defined as isolates from the first and second episode of TB which differ on RFLP analysis. Each study participant who has recurrent TB will be assessed by Interferon (IFN) gamma ELISPOT assay to compare cytotoxic lymphocyte (CTL)immune responses in TB relapse and re-infection.
- Conditions
- Tuberculosis
- Keywords
- Recurrence, Tuberculosis
- Medical subject headings
- Tuberculosis, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Tuberculosis
The primary endpoint of this study will be development of TB. TB recurrence as a result of relapse will be defined as isolates of M.tuberculosis from the first and second episodes of TB which cluster in Restriction Fragment Length Polymerization analysis. TB recurrence as a result of re-infection will be defined as isolates from the first and second episode of TB which differ on RFLP analysis. To detect TB, patients will have a sputum smear at every study visit. Chest X-Ray and safety bloods are conducted 6-monthly.
Measured: Tuberculosis case finding will be conducted over a 36 month period. Tuberculosis investigations will be conducted from the date of Enrollment to the date of TB diagnosis based on a positive sputum TB culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startNov 2009
- Primary completion23 Apr 2014
- Study completion23 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Sponsor type
- Research network
- Collaborators
- United States President's Emergency Plan for AIDS Relief, Howard Hughes Medical Institute, K-RITH
- Responsible party
- Principal investigator, Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa
- Investigators
- Kogieleum Naidoo, MBChB, Principal investigator, Centre for the AIDS Programme of Research in South AfricaSalim S Abdool Karim, MBChB, PhD, Principal investigator, Centre for the AIDS Programme of Research in South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539005
- Sponsor's protocol ID
- CAP005
- Acronym
- TRuTH
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2012
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischinger S, Cizmeci D, Shin S, Davies L, Grace PS, Sivro A, Yende-Zuma N, Streeck H, Fortune SM, Lauffenburger DA, Naidoo K, Alter G. A Mycobacterium tuberculosis Specific IgG3 Signature of Recurrent Tuberculosis. Front Immunol. 2021 Sep 22;12:729186. doi: 10.3389/fimmu.2021.729186. eCollection 2021.
PubMed 34630406
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Tuberculosis Recurrence in Treated Tuberculosis-Human Immunodeficiency Virus (HIV) Co-Infected Patients Relapse or Re-infection?
- ClinicalTrials.gov ID
- NCT01539005
- Acronym / sponsor ID
- TRuTH / CAP005
- Conditions
- Tuberculosis
- Keywords
- Recurrence, Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Centre for the AIDS Programme of Research in South AfricaResearch network
- Collaborators
- United States President's Emergency Plan for AIDS Relief, Howard Hughes Medical Institute, K-RITH
- Study start
- Nov 2009
- Primary completion
- 23 Apr 2014 (actual)
- Study completion
- 23 Apr 2014 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly active antiretroviral therapy (HAART).The primary objective of this study is to determine the incidence of TB recurrence in patients on HAART.The study is being conducted at the CAPRISA eThekwini Clinical Research Site (CRS), which is adjacent to the Prince Cyril Zulu Communicable Disease Clinic (PCZCDC), a major urban TB clinic, in Durban, South Africa.No hypotheses will be tested in this study; however, the primary study question will determine the proportion of TB recurrence due to relapse vs. re-infection.The study has enrolled 402 participants
Detailed description
- Objective: To determine the extent of and reasons for relapse and re-infection in incident cases of tuberculosis (TB) in Human Immunodeficiency Virus (HIV)-infected patients on Highly Active Antiretroviral Therapy (HAART)
- Design: A prospective cohort study of patients with HIV previously treated for pulmonary TB and initiated on HAART in the SAPIT (Starting AIDS treatment at three Points in TB treatment) and START (Starting Tuberculosis and Anti-Retroviral Therapy) trials. Each incident case of TB recurrence in this cohort of adult patients on HAART will be investigated to assess whether the infecting mycobacterium is similar to that from the previous infection and whether the immune responses differ in cases of relapse and re-infection.
- Population: Men and women 18 years of age with documented HIV infection and past TB therapy as part of the SAPIT and START trial will be enrolled.
- Study Procedures: This study will involve 3 years of follow-up of patients who had been initiated on a course of TB therapy as part of the SAPIT and START trials. Upon exit from the SAPIT trial (i.e. 18 months post-TB diagnosis), study patients will be consented and enrolled in this cohort study. Study participants will be seen monthly for the first 3 months and thereafter 3 monthly, for routine clinic visits and ART services. At every visit patients will be screened for TB recurrence clinically, with chest radiograph and, whenever possible, with available TB diagnostics or new diagnostics that are being developed and/or tested.
- Study Outcome The primary endpoint of this study will be the development of recurrent TB. TB recurrence as a result of relapse will be defined as isolates of M. tuberculosis from the first and second episodes of TB which cluster in Restriction Fragment Length Polymerization (RFLP) analysis. TB recurrence as a result of re-infection will be defined as isolates from the first and second episode of TB which differ on RFLP analysis. Each study participant who has recurrent TB will be assessed by Interferon (IFN) gamma ELISPOT assay to compare cytotoxic lymphocyte (CTL)immune responses in TB relapse and re-infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women > 18 years of age with documented HIV infection and past TB therapy as part of the SAPIT and START trial will be enrolled.
Key inclusion criteria (2 listed)
- Adult patients (> 18 years) who were diagnosed as co-infected with TB and HIV and previously enrolled in the SAPIT and START trials
- Willing to consent to participate in this study and contribute specimens to the K-RITH repository for future investigations
Key exclusion criteria (2 listed)
- Patients with Extensively drug-resistant (XDR) TB will not be eligible.
- Patients who refuse consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tuberculosis
Time frame: Tuberculosis case finding will be conducted over a 36 month period. Tuberculosis investigations will be conducted from the date of Enrollment to the date of TB diagnosis based on a positive sputum TB culture
The primary endpoint of this study will be development of TB. TB recurrence as a result of relapse will be defined as isolates of M.tuberculosis from the first and second episodes of TB which cluster in Restriction Fragment Length Polymerization analysis. TB recurrence as a result of re-infection will be defined as isolates from the first and second episode of TB which differ on RFLP analysis. To detect TB, patients will have a sputum smear at every study visit. Chest X-Ray and safety bloods are conducted 6-monthly.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 34630406Fischinger S, Cizmeci D, Shin S, Davies L, Grace PS, Sivro A, Yende-Zuma N, Streeck H, Fortune SM, Lauffenburger DA, Naidoo K, Alter G. A Mycobacterium tuberculosis Specific IgG3 Signature of Recurrent Tuberculosis. Front Immunol. 2021 Sep 22;12:729186. doi: 10.3389/fimmu.2021.729186. eCollection 2021.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kogieleum Naidoo, MBChB principal investigator
Centre for the AIDS Programme of Research in South Africa
Salim S Abdool Karim, MBChB, PhD principal investigator
Centre for the AIDS Programme of Research in South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Feb 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tuberculosis (time frame: Tuberculosis case finding will be conducted over a 36 month period. Tuberculosis investigations will be conducted from the date of Enrollment to the date of TB diagnosis based on a positive sputum TB culture). 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 NCT01539005, 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 2 Feb 2017.