Tuberculosis Clinical Trial
— TRuTHOfficial title:
Is Tuberculosis Recurrence in Treated Tuberculosis-Human Immunodeficiency Virus (HIV) Co-Infected Patients Relapse or Re-infection?
Verified date | February 2017 |
Source | Centre for the AIDS Programme of Research in South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 402 |
Est. completion date | April 23, 2014 |
Est. primary completion date | April 23, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | CAPRISA eThekwini Clinical Research Site | Durban | KwaZulu Natal |
Lead Sponsor | Collaborator |
---|---|
Centre for the AIDS Programme of Research in South Africa | Howard Hughes Medical Institute, K-RITH, United States President's Emergency Plan for AIDS Relief |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 |
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