HIV Infections Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 592 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria for First Part of Study: - 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 Exclusion Criteria for First Part of Study: - 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 - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | King Edward VIII Hospital | Congella | Durban |
South Africa | Prince Cyril Zulu CDC | Congella | Durban |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
South Africa,
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. Review. — View Citation
Corbett 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. Review. — View Citation
de 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. Review. — View Citation
Girardi 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. — View Citation
Girardi 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. — View Citation
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---|---|---|---|---|
Primary | Diagnosis of an AIDS-defining illness | |||
Primary | 18-month mortality |
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