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The Department of Clinical Research at Tuberculosis Research Centre is involved in Controlled Clinical Trials since 1956. It is the hub around which the TRC functions. It is manned by a team of doctors, medical social workers, nursing staffs and supported by other technical personnel. The Department is eminently geared for the conduct of clinical trials in tuberculosis and HIV. This involves the capacity to enroll large numbers of suitable patients and to follow them up over periods varying from 2 to 10 years. The Department has 5 sections namely - Nursing section, Social Workers section, Bio-Informatics section, Clinical Laboratory services and Radiology & Pulmonary physiology laboratory. The Radiology section has an excellent imaging unit which has a digital x-ray and an image archiving system which is used to digitally archive the huge amounts of x-rays of clinical trial participants, and also MMR x-rays of the TB surveys carried out by the epidemiology unit. Head of Department: Dr.Aleyamma Thomas, Scientist F Ongoing Clinical Trials 1. Randomised clinical trial to study the efficacy and tolerability of three times a week gatifloxacin and moxifloxacin containing regimens in the treatment of sputum positive pulmonary tuberculosis 2. Randomized clinical trial to study the efficacy and tolerability of 3- and 4-month moxifloxacin containing regimens in the treatment of sputum smear positive pulmonary tuberculosis 3. Randomized Clinical Trial of 6-month vs. 9-month anti-tuberculosis treatment in HIV positive individuals with pulmonary tuberculosis (NCT00376012) 4. Randomized Clinical trial to determine the efficacy of two different preventive therapy regimens in the prevention of tuberculosis in HIV positive persons. (NCT00351702) 5. A clinical trial to study the efficacy of two different once-daily anti-retroviral regimens along with anti-TB treatment, in patients with HIV-1 and Tuberculosis (NCT00332306) 6. Utility of two antibiotic algorithms and repeat sputum smear microscopy to improve the efficiency of diagnosis in smear negative tuberculosis 7. Evaluation of a Diagnostic Algorithm for HIV positive tuberculosis suspects who are initially smear negative 8. Efficacy and safety of immunomodulator ( Mycobacterium W ) as an adjunct therapy in category II pulmonary tuberculosis 9. Innate and Adaptive Immunity in Children starting Antiretroviral drugs in India 10. Changes in HIV viral load in patients undergoing treatment for filarial infection 11. Nutritional Assessment and Supplementation in HIV infected persons with or without tuberculosis 12. HIV Vaccine study
Other clinical studies 1. Drug Susceptibility profile of M. tuberculosis isolates from patients who remain smear positive at fourth month or later during treatment with Category II Regimen 2. Pharmacokinetics of efavirenz during anti-tuberculosis treatment with rifampicin-containing regimens 3. Monitoring plasma nevirapine and efavirenz levels in HIV-TB co-infected patients undergoing anti-TB and antiretroviral treatment 4. Therapeutic drug monitoring of nevirapine and efavirenz in HIV-infected children in India 5. Feasibility of monitoring antiretroviral treatment adherence using urine & salivary lamivudine: a study in healthy volunteers
Socio Behavioural Research 1. Behavioral Risk Factors and HIV sero-prevalence among men who have sex with men (MSM) in Chennai 2. Private providers and Tuberculosis services: Patient perspectives 3. Perceptions of HIV positive individuals on disclosure of their HIV status to their children. 4. Community-Based Approach to Designing an AIDS Program for HIV+ Mothers in India(MLH)-Collaborative study with the UCLA- University of Los Angeles 5. A study on sexual behaviour among sero discordant individuals. 6. Attitude towards sex and sexuality among seropositive widows who lost their husbands to HIV/AIDS 7. Parental and care givers perceptions on disclosure of HIV diagnosis to sero positive children 8. A study on quality of life among HIV/TB patients on ART 9. A study of the care seeking behaviour of persons with chest symptoms from rural and urban areas in Tamil Nadu after the implementation of the RNTCP 10. Psycho- social dysfunction: perceived and enacted stigma among tuberculosis patients under Revised National
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