HIV Infections Clinical Trial
Official title:
A Study of the Effects of Antiretroviral Therapy on Rates and Transmission of Tuberculosis
Verified date | February 2011 |
Source | CIPRA SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV. This study will also examine the genetics of TB and the relationships among active TB infection, new HIV infections, and HIV disease progression.
Status | Completed |
Enrollment | 1250 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria for All Participants: - Willing to comply with study requirements - Parent or guardian willing to provide informed consent, if applicable Inclusion Criteria for Participants in First Part of the Study: - Live in Masiphumelele Township, Cape Town, South Africa for at least 1 week Inclusion Criteria for Participants in Second Part of the Study: - Live in Masiphumelele Township, Cape Town, South Africa - Registered TB patient at the study site Exclusion Criteria for All Participants: - Currently incarcerated Exclusion Criteria for Participants in Second Part of the Study: - No Mycobacterium tuberculosis specimen obtained from the participant for genetic analysis |
Observational Model: Ecologic or Community, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
South Africa | Desmond Tutu HIV Centre Department of Medicine | Cape Town | Western Cape |
South Africa | Desmond Tutu HIV Centre Department of Medicine | Cape Town |
Lead Sponsor | Collaborator |
---|---|
CIPRA SA | Comprehensive International Program of Research on AIDS, National Institute of Allergy and Infectious Diseases (NIAID) |
South Africa,
Aaron L, Saadoun D, Calatroni I, Launay O, Mémain N, Vincent V, Marchal G, Dupont B, Bouchaud O, Valeyre D, Lortholary O. Tuberculosis in HIV-infected patients: a comprehensive review. Clin Microbiol Infect. 2004 May;10(5):388-98. Review. — View Citation
Badri M, Ehrlich R, Wood R, Pulerwitz T, Maartens G. Association between tuberculosis and HIV disease progression in a high tuberculosis prevalence area. Int J Tuberc Lung Dis. 2001 Mar;5(3):225-32. — View Citation
Friedland G, Harries A, Coetzee D. Implementation issues in tuberculosis/HIV program collaboration and integration: 3 case studies. J Infect Dis. 2007 Aug 15;196 Suppl 1:S114-23. Review. — View Citation
Kwara A, Flanigan TP, Carter EJ. Highly active antiretroviral therapy (HAART) in adults with tuberculosis: current status. Int J Tuberc Lung Dis. 2005 Mar;9(3):248-57. Review. — View Citation
Maher D, Harries A, Getahun H. Tuberculosis and HIV interaction in sub-Saharan Africa: impact on patients and programmes; implications for policies. Trop Med Int Health. 2005 Aug;10(8):734-42. Review. — View Citation
Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis. 2007 Aug 15;196 Suppl 1:S15-27. Review. — View Citation
Wood R, Maartens G, Lombard CJ. Risk factors for developing tuberculosis in HIV-1-infected adults from communities with a low or very high incidence of tuberculosis. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):75-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Microbiologically Confirmed Tuberculosis Infection | At Year 5 | No | |
Primary | Number of Participants With HIV Infection | At Year 5 | No | |
Secondary | Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants | Year 1 to Year 5 | No | |
Secondary | Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART | Year 1 to Year 5 | No | |
Secondary | Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants | Year 1 to Year 5 | No | |
Secondary | Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants | At Year 5 | No |
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