Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
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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 | Intervention |
---|---|
HIV Infections Tuberculosis |
Other: Standardized diagnostic evaluation |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals |
- Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Prevalence of TB in symptomatic and asymptomatic individuals [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Rates of TB drug resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Value of oral candidiasis as a predictor of TB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Sputum samples and blood collection
Enrollment: | 801 |
Study Start Date: | December 2009 |
Study Completion Date: | March 2011 |
Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
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 Name: SDE
|
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
HIV-infected males and females who are not currently receiving ART
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.
Botswana | |
Gaborone Prevention/Treatment Trials CRS | |
Gaborone, Botswana | |
Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS) | |
Molepolole, Botswana | |
Brazil | |
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | |
Manguinhos, Rio de Janeiro, Brazil | |
India | |
BJ Medical College CRS | |
Pune, Maharashtra, India, 411001 | |
NARI Pune CRS | |
Pune, Maharashtra, India, 411026 | |
Malawi | |
University of North Carolina Lilongwe CRS | |
Lilongwe, Malawi | |
Peru | |
Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS | |
Lima, 18, Peru | |
San Miguel CRS | |
San Miguel, Lima, Peru | |
South Africa | |
Soweto ACTG CRS | |
Johannesburg, Gauteng, South Africa, 1864 | |
Wits HIV CRS | |
Johannesburg, Gauteng, South Africa | |
Durban Adult HIV CRS | |
Durban, KwaZulu-Natal, South Africa | |
CAPRISA eThekwini CRS | |
Durban, KwaZulu-Natal, South Africa, 4011 | |
Zimbabwe | |
UZ-Parirenyatwa CRS (30313) | |
Harare, Zimbabwe |
Study Chair: | Susan Swindells, MBBS | University of Nebraska |
Study Chair: | Srikanth Tripathy, MBBS | National AIDS Research Institute, MIDC, Bhosari |
Publications:
Responsible Party: | Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc. |
ClinicalTrials.gov Identifier: | NCT00865826 History of Changes |
Other Study ID Numbers: | ACTG A5253, 1U01AI068636 |
Study First Received: | March 17, 2009 |
Last Updated: | July 20, 2011 |
Health Authority: | United States: Federal Government |
Keywords provided by AIDS Clinical Trials Group:
Pulmonary Tuberculosis Myobacterium Infections |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Mycobacterium Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013