Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings
Implementing Anti-Retroviral Therapy in Resource-Constrained Settings: A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in Subjects Co-Infected With Tuberculosis and HIV
4 other identifiers
interventional
592
1 country
2
Brief Summary
Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in developing countries. The purpose of this study is to test the effectiveness of a combined treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB. Participants will be recruited from resource-poor communities in Durban, South Africa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2004
CompletedFirst Posted
Study publicly available on registry
September 21, 2004
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedMarch 29, 2010
January 1, 2007
September 20, 2004
March 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnosis of an AIDS-defining illness
18-month mortality
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- TB infected
- Currently receiving standard anti-TB therapy (isoniazid, rifampicin, ethambutol, and pyrazinamide)
- Currently participating in the Prince Cyril Zulu CDC Directly Observed Therapy (DOT) program and receiving treatment daily either there or in the community with a supervised community nurse or trained health worker
- Intending to stay in the area for the duration of the study
- Willing to participate in all follow-up visits
- Willing to use acceptable forms of contraception
- Female participants must be willing to have regular pregnancy tests during ART
You may not qualify if:
- Have had 28 days or more of cumulative ART prior to study entry. Participants who have taken mother-to-child transmission (MTCT) and postexposure prophylaxis (PEP) prevention treatments are not excluded.
- Less than 10 days or greater than 28 days since starting current TB treatment
- Body temperature greater than 38.5 C (101.3 F)
- Rash, nausea, or vomiting of Grade 3 or higher
- Hospitalized or referred for hospitalization for care and treatment of opportunistic infections, TB, or other causes at screening or enrollment
- CD4 count less than 50 cells/microL within 28 days of study entry
- TB meningitis or TB that has spread to the blood and organs other than the lungs
- History of prior TB treatment or previous active TB episode unresponsive to a standard anti-TB regimen
- History of or current AIDS-defining condition as defined by the World Health Organization (WHO)
- History of or current pancreatitis
- Peripheral neuropathy of Grade 2 or higher
- Currently taking certain medications
- Suspected multidrug resistant (MDR) TB
- Any condition that, in the opinion of the investigator, may interfere with the study
- Participation in any other study that may interfere with this study
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
King Edward VIII Hospital
KwaKhangela, Durban, South Africa
Prince Cyril Zulu CDC
KwaKhangela, Durban, South Africa
Related Publications (6)
Cahn P, Perez H, Ben G, Ochoa C. Tuberculosis and HIV: a partnership against the most vulnerable. J Int Assoc Physicians AIDS Care (Chic). 2003 Jul-Sep;2(3):106-23. doi: 10.1177/154510970300200303.
PMID: 14556429BACKGROUNDCorbett EL, Watt CJ, Walker N, Maher D, Williams BG, Raviglione MC, Dye C. The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med. 2003 May 12;163(9):1009-21. doi: 10.1001/archinte.163.9.1009.
PMID: 12742798BACKGROUNDde Jong BC, Israelski DM, Corbett EL, Small PM. Clinical management of tuberculosis in the context of HIV infection. Annu Rev Med. 2004;55:283-301. doi: 10.1146/annurev.med.55.091902.103753.
PMID: 14746522BACKGROUNDGirardi E, Antonucci G, Vanacore P, Palmieri F, Matteelli A, Iemoli E, Carradori S, Salassa B, Pasticci MB, Raviglione MC, Ippolito G; GISTA-SIMIT Study Group. Tuberculosis in HIV-infected persons in the context of wide availability of highly active antiretroviral therapy. Eur Respir J. 2004 Jul;24(1):11-7. doi: 10.1183/09031936.04.00109303.
PMID: 15293599BACKGROUNDGirardi E, Goletti D, Antonucci G, Ippolito G. Tuberculosis and HIV: a deadly interaction. J Biol Regul Homeost Agents. 2001 Jul-Sep;15(3):218-23.
PMID: 11693427BACKGROUNDGengiah TN, Holford NH, Botha JH, Gray AL, Naidoo K, Abdool Karim SS. The influence of tuberculosis treatment on efavirenz clearance in patients co-infected with HIV and tuberculosis. Eur J Clin Pharmacol. 2012 May;68(5):689-95. doi: 10.1007/s00228-011-1166-5. Epub 2011 Nov 23.
PMID: 22108776DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Salim S. Abdool Karim, MBChB, PhD
University of KwaZulu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 20, 2004
First Posted
September 21, 2004
Study Start
August 1, 2009
Last Updated
March 29, 2010
Record last verified: 2007-01