Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy
NCT01539005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 402
Last updated 2017-02-02
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
Conditions
Sponsors & Collaborators
-
United States President's Emergency Plan for AIDS Relief
collaborator FED -
Howard Hughes Medical Institute
collaborator OTHER -
K-RITH
collaborator OTHER -
Centre for the AIDS Programme of Research in South Africa
lead NETWORK
Principal Investigators
-
Kogieleum Naidoo, MBChB · Centre for the AIDS Programme of Research in South Africa
-
Salim S Abdool Karim, MBChB, PhD · Centre for the AIDS Programme of Research in South Africa
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2014-04-23
- Completion
- 2014-04-23
Countries
- South Africa
Study Locations
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