Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy

NCT01539005 | Completed DMC

• 1 other identifier: CAP005
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis

Keywords

Recurrence; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for the AIDS Programme of Research in South Africa: lead
• United States President's Emergency Plan for AIDS Relief: collaborator
• Howard Hughes Medical Institute: collaborator
• K-RITH: collaborator

Study Sites (1)

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (1)

• Fischinger S, Cizmeci D, Shin S, Davies L, Grace PS, Sivro A, Yende-Zuma N, Streeck H, Fortune SM, Lauffenburger DA, Naidoo K, Alter G. A Mycobacterium tuberculosis Specific IgG3 Signature of Recurrent Tuberculosis. Front Immunol. 2021 Sep 22;12:729186. doi: 10.3389/fimmu.2021.729186. eCollection 2021.

  PMID: 34630406 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Tuberculosis; Recurrence

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 27, 2012
• Study Start: November 1, 2009
• Primary Completion: April 23, 2014
• Study Completion: April 23, 2014
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

ZA (1)