Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy (TRuTH)
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 10, 2012 | ||||||||
| Last Updated Date | February 21, 2012 | ||||||||
| Start Date ICMJE | November 2009 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01539005 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy | ||||||||
| Official Title ICMJE | Is Tuberculosis Recurrence in Treated Tuberculosis-Human Immunodeficiency Virus (HIV) Co-Infected Patients Relapse or Re-infection? | ||||||||
| 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 |
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| Detailed Description |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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. |
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| 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. |
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| Condition ICMJE | Tuberculosis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 402 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | South Africa | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01539005 | ||||||||
| Other Study ID Numbers ICMJE | CAP005 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr Kogieleum Naidoo, Centre for the AIDS Programme of Research in South Africa | ||||||||
| Study Sponsor ICMJE | Centre for the AIDS Programme of Research in South Africa | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Centre for the AIDS Programme of Research in South Africa | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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