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Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy (TRuTH)

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ClinicalTrials.gov Identifier: NCT01539005
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
United States President's Emergency Plan for AIDS Relief
Howard Hughes Medical Institute
K-RITH
Information provided by (Responsible Party):
Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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

Condition or disease
Tuberculosis

Detailed Description:
  1. 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)
  2. 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.
  3. 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.
  4. 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.
  5. 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
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Study Type : Observational
Actual Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Tuberculosis Recurrence in Treated Tuberculosis-Human Immunodeficiency Virus (HIV) Co-Infected Patients Relapse or Re-infection?
Study Start Date : November 2009
Actual Primary Completion Date : April 23, 2014
Actual Study Completion Date : April 23, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

Stored Plasma/Serum/PBMCs: Participants who consent to have additional samples stored for future testing will have serum, plasma and PBMCs stored . Possible uses of plasma include assessment of host genetics profiles, including HLA profile, additional viral load assays.Possible uses of serum include additional safety serology and evaluation of suspected IRIS on participants where indicated. The PBMCs will be used to test for IRIS/PR when suspected.

Other potential tests that may be performed on the stored specimens include new generation assays of immunity.

Stored Sputum Isolates :RFLP testing will be performed from stored bacterial isolates on all positive cultures in which recurrence is suspected and compared to the initial positive culture used to diagnose the TB initially.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Adult patients (> 18 years) who were diagnosed as co-infected with TB and HIV and previously enrolled in the SAPIT and START trials
  2. Willing to consent to participate in this study and contribute specimens to the K-RITH repository for future investigations

Exclusion Criteria:

  1. Patients with Extensively drug-resistant (XDR) TB will not be eligible.
  2. Patients who refuse consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539005


Locations
South Africa
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu Natal, South Africa, 4001
Sponsors and Collaborators
Centre for the AIDS Programme of Research in South Africa
United States President's Emergency Plan for AIDS Relief
Howard Hughes Medical Institute
K-RITH
Investigators
Principal Investigator: Kogieleum Naidoo, MBChB Centre for the AIDS Programme of Research in South Africa
Principal Investigator: Salim S Abdool Karim, MBChB, PhD Centre for the AIDS Programme of Research in South Africa
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr Kogieleum Naidoo, Principal Investigator, Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier: NCT01539005     History of Changes
Other Study ID Numbers: CAP005
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa:
Recurrence
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Recurrence
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Disease Attributes
Pathologic Processes