Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Study Details
Study Description
Brief Summary
An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts of the public health and health care infrastructure in many countries where HIV infection has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV prevalence. The primary purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.
This observational study will include participants who are HIV-infected and TB-uninfected and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days. Screening and study entry may occur at the same visit. All evaluations must be performed within 14 days after the participant is registered. Medical and medication history, physical exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation of PPD/TST (if available) will occur within this 14-day period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 HIV-infected males and females who are not currently receiving ART |
Other: Standardized diagnostic evaluation
Participants will undergo a diagnostic evaluation for TB at study entry
Other Names:
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Outcome Measures
Primary Outcome Measures
- Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB [Throughout study]
Secondary Outcome Measures
- Prevalence of TB in symptomatic and asymptomatic individuals [Throughout study]
- Rates of TB drug resistance [Throughout study]
- Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts [Throughout study]
- Value of oral candidiasis as a predictor of TB [Throughout study]
- Significance of investigational serologic assay when added to sputum acid-fast bacilli (AFB) smears when identifying participants with active TB compared to AFB smears alone [Throughout study]
- Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors [Throughout study]
Eligibility Criteria
Criteria
Inclusion Criteria:
- HIV-infected
Exclusion Criteria:
-
Receipt of ART within 90 days prior to study entry
-
Diagnosis of active TB (pulmonary or extrapulmonary) within 90 days prior to study entry
-
Receipt of 7 or more cumulative days of certain medications within 90 days prior to study entry. More information on this criterion can be found in the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gaborone Prevention/Treatment Trials CRS | Gaborone | Botswana | ||
| 2 | Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS) | Molepolole | Botswana | ||
| 3 | Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | Manguinhos | Rio de Janeiro | Brazil | |
| 4 | BJ Medical College CRS | Pune | Maharashtra | India | 411001 |
| 5 | NARI Pune CRS | Pune | Maharashtra | India | 411026 |
| 6 | University of North Carolina Lilongwe CRS | Lilongwe | Malawi | ||
| 7 | San Miguel CRS | San Miguel | Lima | Peru | |
| 8 | Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS | Lima | Peru | 18 | |
| 9 | Soweto ACTG CRS | Johannesburg | Gauteng | South Africa | 1864 |
| 10 | Wits HIV CRS | Johannesburg | Gauteng | South Africa | |
| 11 | CAPRISA eThekwini CRS | Durban | KwaZulu-Natal | South Africa | 4011 |
| 12 | Durban Adult HIV CRS | Durban | KwaZulu-Natal | South Africa | |
| 13 | UZ-Parirenyatwa CRS (30313) | Harare | Zimbabwe |
Sponsors and Collaborators
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
- Study Chair: Susan Swindells, MBBS, University of Nebraska
- Study Chair: Srikanth Tripathy, MBBS, National AIDS Research Institute, MIDC, Bhosari
Study Documents (Full-Text)
None provided.More Information
Publications
- Aichelburg MC, Rieger A, Breitenecker F, Pfistershammer K, Tittes J, Eltz S, Aichelburg AC, Stingl G, Makristathis A, Kohrgruber N. Detection and prediction of active tuberculosis disease by a whole-blood interferon-gamma release assay in HIV-1-infected individuals. Clin Infect Dis. 2009 Apr 1;48(7):954-62. doi: 10.1086/597351.
- Ani AE. Advances in the laboratory diagnosis of Mycobacterium tuberculosis. Ann Afr Med. 2008 Jun;7(2):57-61. Review.
- ACTG A5253
- 1U01AI068636