CompletedNot Applicable

Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy

South Africa402 participantsStarted 2009-11

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Patients with Extensively drug-resistant (XDR) TB will not be eligible.
✕. Patients who refuse consent

What they're measuring

Tuberculosis

Timeframe: 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

Trial details

NCT IDNCT01539005

SponsorCentre for the AIDS Programme of Research in South Africa

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2014-04-23

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