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

February 1, 2017 updated by: Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4001
        • CAPRISA eThekwini Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for the AIDS Programme of Research in South Africa

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 23, 2014

Study Completion (Actual)

April 23, 2014

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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