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Volume 7, Issue 5 (Suppl)

J Clin Trials, an open access journal

ISSN:2167-0870

Clinical Trials 2017

September 11-13, 2017

September 11-13, 2017 San Antonio, USA

4

th

International Conference on

Cl inical Tr ial s

More is not better: The result from a US government sponsored multi-center randomized international

clinical trial to prevent tuberculosis in HIV/AIDS population

Jing Bao

National Institutes of Health, USA

Background:

Tuberculosis (TB) and HIV/AIDS have been closely linked since the beginning of AIDS epidemic. TB is the

most common co-infection and cause of death among the AIDS population. And yet, there isn’t rapid, accurate, and reliable

diagnosis methodology for TB testing, especially in resource-limited countries. Treating HIV/AIDS patients with the available

4 TB drugs has been utilized in in some African countries to manage AIDS patients that were potentially afflicted with TB not

diagnosed. In order to evaluate this treatment/prevention strategy for such patient population, the Division of AIDS at the

National Institute of Allergy and Infectious Diseases, one of the 27 institutes and Centers of the National Institutes of Health,

funded/sponsored a multicenter international clinical trial project.

Methods:

An open label, randomized clinical trial was conceived in 2008 and the first patient was enrolled in October 2011. The

study completed the last patient follow-up in June 2014. The protocol included two arms. Arm A received standard anti-HIV

treatment therapy plus four anti-TB drugs, Isonizid (INH), Rifampin (RIF), Pyrozinamide (PZA), and Ethambutol (EMB).

Arm B received standard anti- HIV treatment plus isoniazid, a WHO recommended strategy to prevent TB. All participants

had CD4 counts less than 50 per μL.

Results & Conclusion:

The trial enrolled 850 patients and conducted in 18 clinical trial sites in Malawi, South Africa, Haiti,

Kenya, Zambia, India, Brazil, Zimbabwe, Peru, and Uganda. We hypothesized the empirical treatment would reduce the

mortality in this patient population. However, the results from the trial showed that the mortality rate was same for both study

arms. Furthermore, the TB incident rates in Arm A were significantly higher in the treatment arm compared to control arm

(33 versus 19). The results illustrated that that adding RIF, PZA, and EMB were not helpful, and possibly harmful. Drug-drug

interactions maybe one of the reasons and the real-time drug concentration tests are among the other measurements to explain

these study results.

Biography

Jing Bao is a Medical Officer at the division of AIDS, National Institute of Allergy and Infectious Diseases, Columbus Technologies and Services, Inc., with extensive

experience in international clinical trial oversight and global regulations. She manages and oversees the US government (National Institutes of Health) funded/

sponsored international multi-center clinical trials on treatment development for HIV/AIDS and co-infections. She received her MD from China and was a Medical

Director for two hospitals before she received a PhD from Israel. She has published influential research findings in world leading journals. She is the Member of

Asian American Executives Network and will be graduated from its Senior Executive Service Candidate Development Program in April 2017.

baoj@niaid.nih.gov

Jing Bao, J Clin Trials 2017, 7:5 (Suppl)

DOI: 10.4172/2167-0870-C1-019