clinical department

Epidemiological Research | Clinical Pathology | Immunology | Bacteriology | Statistical Studies | Collaborative Studies

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
    Principal Investigator: Dr. Rajeswari Ramachandran
    Funding: Indian Council of Medical Research

Shortening the duration of treatment for tuberculosis is a research priority for TB control The currently recommended 6-month regimen has been in use for more than 30 years. Recently the TRC carried out a randomized clinical trial which demonstrated for the first time that newly diagnosed pulmonary TB patients can be effectively treated with a 4-month daily regimen that used ofloxacin instead of ethambutol in the 4-drug regimen ( Indian Journal of Tuberculosis 2002 ). However, the delivery of a daily treatment under the DOTS strategy poses logistic problems. The centre therefore is conducting a randomized clinical trial in which the efficacy and safety of thrice-weekly 4-month gatifloxacin or moxifloxacin regimens are compared with that of the standard 6-month thrice-weekly regimen. The study is being carried out in Chennai and Madurai. An interim analysis has shown that the relapse rates in both the gatifloxacin and moxifloxacin regimens are significantly higher compared to the control regimen. Intake to the study has therefore been suspended on the recommendations of the Data and Safety Monitoring Board. The follow-up of patients who have already completed treatment is in progress.

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
    Principal Investigator: Dr. M S Jawahar
    Funding: Indian Council of Medical Research

Clinical trials by the TRC have shown that while a 4-month daily regimen which included ofloxacin in the intensive phase was successful in the treatment of sputum positive pulmonary tuberculosis, 4-month thrice weekly regimens with ofloxacin, gatifloxacin or moxifloxacin were less successful with high relapse rates. Following publication of the TRC clinical trial demonstrating the efficacy of an ofloxacin containing regimen in shortening TB treatment to 4 months ( Indian Journal of Tuberculosis 2002), there has been a global interest in the role of the quinolones in the primary treatment of tuberculosis. Moxifloxacin is now considered the most effective of the quinolones for treatment of tuberculosis due to its many unique qualities. The TRC is now proposing to study the efficacy and safety of 3- and 4-month moxifloxacin containing regimens for treatment of patients with sputum positive pulmonary tuberculosis. Newly diagnosed smear positive pulmonary tuberculosis patients will be randomly allocated to 3-month or 4-month moxifloxacin regimens or a control 6-month regimen. The study will be carried out in Chennai and Madurai and is expected to start patient enrollment in the last week of May.

3. Randomized Clinical Trial of 6-month vs. 9-month anti-tuberculosis treatment in HIV positive individuals with pulmonary tuberculosis (NCT00376012)
Principal Investigator: Dr. Soumya Swaminathan
Funding: Indian Council of Medical Research: HIV-TB Task Force

The HIV infection has increased the burden of TB, especially in populations where the prevalence of TB infection is high among young adults. Among HIV-infected persons there is a prime need for early and accurate detection of smear positive TB to prevent further spread in the community, and there is also a need to accurately diagnose and treat smear-negative cases not only for individual health benefits but also to reduce the number of smear-positive cases that arise in future. It is unknown whether the current diagnostic criteria and investigations recommended by the RNTCP are adequate to effectively diagnose tuberculosis in HIV positive persons. Under the RNTCP, HIV assoiciated TB patients are currently being treated with the standard regimens, but the effectiveness of these regimens among TB patients with HIV infection is unknown. Given the serious threat posed by the HIV epidemic on control of TB, and the current gaps in knowledge related to diagnosis and treatment of TB among HIV-infected persons in the Indian population, it was proposed to conduct a randomized control clinical study with the following aims:
(i) To assess the efficacy of RNTCP regimen among HIV infected persons with pulmonary or extrapulmonary TB
(ii) To evaluate any additional benefit of an extended continuation phase in reducing failures and relapses
(iii) To study the relationship between stage of HIV disease and response to anti-TB treatment
(iv) To study recurrences and their nature (relapse/reinfection) using RFLP pattern
Adult patients with HIV and TB were randomized to receive the standard 6-month short course intermittent anti-TB treatment (2EHRZ₃/4HR₃) (RNTCP Category I) or an extended continuation phase 9-month regimen (2EHRZ₃/7HR₃). Patients are followed up to 3 years. Apart from sputum smear and culture for mycobacteria, CD4 counts and viral load were also done periodically to assess response to treatment and disease progression. Outcome measures include sputum conversion, cure and relapse rates. A total of 334 patients were recruited and followed for 3 years. This study will provide information on whether Category I treatment is sufficient for HIV TB patients.

4. Randomized Clinical trial to determine the efficacy of two different preventive therapy regimens in the prevention of     tuberculosis in HIV positive persons. (NCT00351702)
    Principal Investigator: Dr. Soumya Swaminathan
    Funding: United States Agency for International Development (USAID)

Preventive therapy against TB with the use of one or more anti-TB drugs given to patients with latent infection with Mycobacterium tuberculosis in order to prevent the progression to active disease.

Although there is large body of literature indicating benefit from preventive therapy, particularly among Mantoux Test positive persons, several issues regarding preventive therapy for tuberculosis in HIV positive persons need to be addressed in the endemic Indian setting. The efficacy of preventive therapy in Mantoux negative HIV positive persons has not been clearly established. The duration of preventive therapy required in an endemic setting is another area requiring further investigation. The current trial aims to compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons.

Persons with HIV infection without past or current TB are randomized to one of the two arms: 6 months Ethambutol + isoniazid (6EH) vs. 3 years Isoniazid alone (36H). They are being followed for the development of tuberculosis, up to 3 years. A total of 711 individuals have been recruited. The rationale of this study is to find out if a long duration/lifelong prophylaxis for TB would be better than a short course. Interim results will be availbale by end of 2008. The results of this trial will have implications for the National AIDS and TB control programs.

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)
    Principal Investigator: Dr. Soumya Swaminathan
    Funding: National AIDS Control Organization (NACO), India

HIV infected individuals have a 60-70% lifetime risk of developing TB. TB accelerates HIV disease progression by increasing the plasma viral load and decreasing the CD4 cell counts. Hence, in addition to treating TB, antiretroviral therapy would be of benefit in improving immune system, TB outcome & the quality of life, reducing plasma viral load, morbidity and mortality.

The main reason for poor long-term result with antiretroviral therapy (HAART) are issues of Non adherence. Trials administering HAART as DOT have shown near perfect virologic success. But, DOT will be feasible only for once daily therapy.

Evaluation of many HAART regimens world-wide have shown efavirenz-containing regimens to be superior in terms of efficacy and toxicity profile and efavirenz is the preferred NNRTI in combination with rifampicin. Nevirapine forms the backbone of ART regimens in resource-poor settings as it has cost advantage. Few observational and pharmacokinetic studies combining both nevirapine and rifampicin have suggested that they can be used together.

This randomized clinical trial will study the efficacy and safety of two different once-daily antiretroviral regimens along with anti-TB treatment in the treatment of HIV-infected TB patients. The objectives are to study a once-daily regimen of ddI+ Lamivudine+ Efavirenz/Nevirapine along with standard ATT in patients with HIV and TB with CD4< 250. The primary outcome measure is suppression of viral load after 24 weeks of ART. A secondary outcome variable is to study the utility of DOT in this setting vs self-administered ART. Pharmacokinetic studies are being planned concurrently to study the interaction between rifampicin and nevirapine/efavirenz. The trial started in May 2006 with recruitment at Chennai, Madurai and Vellore. 140 patients have been enrolled till February 2008.

6. Utility of two antibiotic algorithms and repeat sputum smear microscopy to improve the efficiency of diagnosis in     smear negative tuberculosis
    Principal Investigator: Dr. D Baskaran
    Funding: Indian Council of Medical Research

The diagnosis of smear negative pulmonary TB is vital as these cases are likely to break down to smear positive cases if left untreated. This study aims to evaluate the utility of two antibiotic algorithms to improve the efficiency of diagnosis of smear negative TB and to determine the role of repeat sputum microscopy for persistent chest symptomatics after a course of antibiotics.

The secondary objective of this study includes determining the proportion of TB patients among this group (confirmed by culture) and their correlation with chest x-ray finding. The etiological profile of respiratory infections and their sensitivity pattern and appropriateness of antibiotic algorithm will also be evaluated by this study. Patients with 3 weeks of cough and 3-sputum smears negative by sputum smear microscopy will be recruited to the study. It is proposed to admit 700 patients to each antibiotic arm.

Patients will be randomly allocated to one of the following antibiotic regimens:

1) Tab.Co-trimoxazole 160 mg twice daily for 10 days

2) Cap.Doxycycline 100mgm twice daily on first day then once daily for 4 days followed by Cap. Amoxicillin 500mg three daily for 5 days

The study began enrolling patients in March 2006 and the trial is currently in progress.

7. Evaluation of a Diagnostic Algorithm for HIV positive tuberculosis suspects who are initially smear negative
Principal Investigator: Dr. Padmapriyadarsini
Funding: United States Agency for International Development ( USAID )

Since the advent of HIV there has been a disproportionate increase in the reported rates of smear negative TB. There is a delay in diagnosing this condition leading to a higher mortality rate. WHO has recommended certain revisions in the existing guidelines to diagnose smear negative TB in HIV positive patients. This differs from RNTCP guidelines that are currently being practiced in India. The primary objective of the present study is to develop & evaluate a diagnostic algorithm for HIV positive persons suspected to have TB, but who are smear negative for AFB during the initial screening for TB and the secondary objective is to determine the utility of initial chest x-ray (CXR) & sputum culture, in the diagnostic algorithm. Patient enrollment to this study started in February 2007.

8. Efficacy and safety of immunomodulator ( Mycobacterium W ) as an adjunct therapy in category II pulmonary tuberculosis
Principal Investigator: Dr.Rajeswari Ramachandran
Funding: Department of Biotechnology, Government of India

The immunomodulator containing Mycobacterium w was developed by the National Institute of Immunology, New Delhi in 1980. It has been found to be useful in the prevention of TB in experimental animals. A pilot study conducted to evaluate the role of Mycobacterium w in improving sputum conversion rate in pulmonary TB, showed that the conversion rate was faster when Mycobacterium w was added to the short course regimen. Immunomodulators work against persistors, which may result in reducing the relapse rates.

A double blinded, randomized, placebo controlled, multicentric clinical trial has been initiated by the Department of Science and Technology. This is being done with the aim of studying the cure rate in Category II pulmonary TB patients after the addition of the Mycobacterium w vaccination to standard anti-TB drugs. The patients are randomly chosen to receive either the vaccine or placebo along with the standard category II RNTCP regimen. One hundred and twenty eight patients are proposed to be admitted to the trial.

The study was initiated in March 2006 and in one-year period 57 patients were screened and 30 have been included in the study. The study is on going.

9. Innate and Adaptive Immunity in Children starting Antiretroviral drugs in India
Principal Investigator: Dr. Soumya Swaminathan
Funding: Indo-US JWG on Maternal and Child Health (NIH and ICMR)

Pediatric HIV continues to be a serious problem in India with an estimated 30-50,000 children being born each year with HIV infection every year. Access to antiretroviral therapy is increasing through Government ART centers. This project proposes to provide insight into HIV disease pathogenesis that have implications on future management of children with HIV infection. We will be testing the hypothesis that studying the naive CD4 T cells, CD 127, CD8 T cells and dendritic cell function will provide better predictive information on disease progression than monitoring CD4 cell counts alone.

The goals of this study are to understand the immunopathogenesis and to identify the novel immunologic markers that would lead to better insight into when to start and when to change therapy in HIV infected children. The study will provide information on the response to standard antiretroviral therapy in HIV infected Indian children using standard markers of CD4 and viral load. Concurrently novel markers will be investigated and linked to standard markers to better define thresholds for treatment initiation and change.

Currently, a cohort of about 150 HIV-infected children is being followed up at TRC, about a third are on ART. Immunological studies (surface markers on CD4 and CD8 cells as well as dendritic cell assays) to identify markers of disease progression in pediatric HIV are being undertaken. The study is in collaboration with Dr. Savita Pahwa, Director Division of HIV and Microbiology, University of Miami, Florida. Patient enrollment to this study started in February 2007. So far, 25 children have been enrolled into the study.

10. Changes in HIV viral load in patients undergoing treatment for filarial infection
Principal Investigator: Dr. Soumya Swaminathan
Funding: National Institute of Allergy and Infectious Diseases (NIAID), USA

Evidence is beginning to accumulate that the course of HIV infection and progression to AIDS may be influenced by co-existing infections, other than the classic opportunistic infections. The interaction of helminth infections with HIV has not been well established. Some studies have shown that patients with HIV and concomitant helminth infections have higher viral loads which decrease upon treatment whereas others have shown no effect of helminths on viral load, CD4 count or disease progression.

Few studies have looked at the interaction of filarial disease with HIV. In lymphatic filariasis (LF), the microfilaremic form is characterized by a predominance of antigen-reactive T cells with a Th2 phenotype associated with production of IL-4, IL-5, IL-10, and IgE . Previous evidence suggest that in many situations HIV appears to replicate more efficiently in Th2-conditioned cell lines rather than Th1 cell lines. If indeed the immune alterations due to parasitic infections potentiate initial infection and subsequent replication of HIV, rigorous treatment and control of parasitic infections, including LF, might slow the spread of HIV and the progression to AIDS, especially in the developing world. This study aims to determine the changes in HIV viral loads that occur in patients co-infected with HIV and filaria, over 1 year following treatment with Diethycarbamazepine/Albendazole and to compare those changes with HIV infected patients without filarial co-infections. Intake to the study started in July 2007.

11. Nutritional Assessment and Supplementation in HIV infected persons with or without tuberculosis
Principal Investigator: Dr. Soumya Swaminathan
Funding: World Food Program, India

A study of nutritional abnormalities in HIV-infected persons and an intervention using a food supplement (high-calorie, high-protein) was initiated with the assistance of the World Food Program. The objective was to document baseline macro and micronutrient deficiencies in persons with HIV infection, at different stages of the disease and try to improve nutritional status by giving a high-calorie, high protein food supplement. HIV-infected patients, especially those with tuberculosis were found to have lower body weight, BMI and were more anemic than socio-economically matched controls. Interim findings show a significant increase in body weight and BMI, with nutritional supplementation.

12. HIV Vaccine study
Principal Investigator: Dr. V. D. Ramanathan
Funding: International AIDS Vaccine Initiative (IAVI)

In view of the existing burden of HIV infection with its medical, social and economic dimensions, it was decided that efforts should be undertaken to test a vaccine against HIV as per the joint declaration by the NACO, ICMR and the International AIDS Vaccine Initiative. For this purpose, a phase I trial of a multigenic vaccine against HIV- 1 subtype C using Modified Vaccinia Ankara (MVA) as the vector has been initiated.

State of the art safety and immunology laboratories have been set up, staff trained in Good Clinical Practice, Good Clinical Laboratory Practice and the entire laboratory and recruitment oriented activities.

A total of 32 healthy, at-low risk volunteers have been enrolled in the study and have received 3 injections of either placebo, a lower dose or a higher dose of the vaccine (in groups of 8, 12 and 12, respectively). There have been no vaccine related adverse effects in the 8-12 month follow up so far.

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
    Principal Investigator: Dr. Pauline Joseph
    Funding: United States Agency for International Development (USAID)

Category II (2EHRZS 3/ 1EHRZ 3/ 5HRE 3) regimen is the re-treatment regimen of RNTCP. Patients who fail on category II regimen have to be referred to a speciality centre for culture and drug susceptibility testing (DST) and for further management.

This study aims to assess the drug susceptibility profile of M. tuberculosis isolates from patients who remain smear positive at fourth month or later during treatment with Category II regimen. Patients for this study are recruited from Tiruvellore District (all 6 TB units) and Chennai Corporation area. Two sputum specimens are collected from all patients; on category II regimen and those who remain smear positive at fourth month or later, for drug susceptibility testing. It is planned to include 250 patients to the study.

2. Pharmacokinetics of efavirenz during anti-tuberculosis treatment with rifampicin-containing regimens
Principal Investigator: Dr. Soumya Swaminathan
Funding: Tamil Nadu State AIDS Control Society

Efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor has been recommended as a first line option in antiretroviral treatment (ART) and the preferential choice in TB and HIV co-infected patients. Despite few studies demonstrating favourable clinical outcomes in HIV-TB patients receiving EFV and RMP concomitantly, serious concerns have been raised regarding the adequacy of the conventional dose of EFV (600mg once daily) when co-administered with RMP, particularly in patients with higher body weight. This study was carried out in collaboration with the Government Hospital of Thoracic medicine, Tambaram, Chennai. The aims of the study were as follows:

i. To compare the pharmacokinetics of efavirenz in HIV and TB co-infected patients during and after completion of anti-TB treatment with rifampicin -containing regimens

ii. To assess the pharmacokinetics of rifampicin during efavirenz co-administration

3. Monitoring plasma nevirapine and efavirenz levels in HIV-TB co-infected patients undergoing anti-TB and     antiretroviral treatment
    Principal Investigator: Dr. Soumya swaminathan, Dr. Geetha Ramachandran
    Funding: Tamil Nadu State AIDS Control Society

HIV-infected patients with tuberculosis (TB) merit special considerations because co-management of both diseases is complicated by potential pharmacological drug interactions between rifampicin (RMP) and the non-nucleoside reverse transcriptase inhibitors (NNRTI), risk of drug toxicity, high pill burden and adherence. Although it is known that RMP significantly reduces the bioavailability of efavirenz (EFV) and nevirapine (NVP), the clinical significance of this reduction is unclear. In this study, it is proposed to estimate trough concentrations of nevirapine and efavirenz in HIV-TB patients who get admitted into an ongoing controlled clinical trial in which the patients are receiving antiretroviral and anti-TB treatment. It is proposed to conduct this study in 50 patients. These patients will be tested at 4 time points during the clinical trial, that is, at 1, 4, 6 and 12 months after start of antiretroviral treatment. The drug levels will be correlated with the patients' viral load, CD4 cell counts and drug resistance patterns. The study would provide useful information on the impact of reduced bioavailability of the NNRTIs during RMP co-administration on treatment outcome.

4. Therapeutic drug monitoring of nevirapine and efavirenz in HIV-infected children in India
Principal Investigator: Dr. Soumya swaminathan
Funding: Indian council of Medical research

Pharmacokinetic data and evidence – based dosage recommendations of antiretroviral drugs in children is very limited. Antiretroviral drugs for pediatric use have been very recently introduced by the Government of India and are made available at the Government ART centres. Limited information is available on the blood levels of NVP and EFV in children receiving the pediatric formulations in India. A study was therefore planned to estimate the trough and peak levels of NVP in HIV-infected children receiving treatment with generic pediatric formulations and examine if drug levels are within the therapeutic range of the drugs. This study would lay the groundwork for further pharmacokinetic studies of antiretroviral drugs in children.

The study is done in collaboration with the B.J.Wadia Hospital, Mumbai. HIV-infected children receiving treatment at the Government ART centres at the Government Rajaji Hospital, Madurai, B.J.Wadia Hospital, Mumbai, Government Hospital of Thoracic Medicine, Tambaram and Kilpauk Medical College and Hospital, Kilpauk will form the study population. It has been proposed to include about 100 children in the study .

5. Feasibility of monitoring antiretroviral treatment adherence using urine & salivary lamivudine: a study in healthy     volunteers
    Principal Investigator: Dr. Soumya Swaminathan, Dr. A.K. Hemanth Kumar

Adherence to antiretroviral treatment (ART) is a strong predictor of virological suppression, disease progression and death. Detection of antiretroviral drugs in blood, urine or saliva would be useful in monitoring patient adherence to treatment. A study has been initiated in healthy volunteers, to assess the feasibility of using urine or salivary concentrations of lamivudine to monitor treatment adherence. This study is done in collaboration with the Madras Medical College, Chennai. It is proposed to include 12 healthy volunteers into the study. The study would provide information on the quantity and extent of excretion of lamivudine in urine and saliva over a period of time. This would enable us to work out a cut-off value that could be used to test patients' adherence to antiretroviral treatment .

Socio Behavioural Research

Ongoing Studies

1. Behavioral Risk Factors and HIV sero-prevalence among men who have sex with men (MSM) in Chennai
Principal Investigator: Dr. Beena Thomas
Funding: National Institute of Allergy and Infectious Diseases ( NIAID), USA

This is a behavioral sero-epidemiological study of men who have sex with men (MSM) in Chennai, India. The project will recruit 200 MSMs in Chennai, who will be provided HIV counseling testing for, and administered an assessment inventory of HIV-risk and related variables among . All participants will be enrolled at TRC in Chennai. This psychosocial risk assessment battery targeting MSM in Chennai will be based on similar batteries used in large cohort studies of MSMs in the U.S.A.

2. Private providers and Tuberculosis services: Patient perspectives
Principal Investigator: Dr.Rajeswari Ramachandran
Funding: Indian Council of Medical Research

In 1997 during National Tuberculosis control programme(NTP) period, 203 Tuberculosis (TB) patients, and in 2005 after implementation of Revised National Tuberculosis control programme (RNTCP) 104 TB patients, who discontinued anti-TB treatment from Private Practitioners (PPs) and switched over to public provider were interviewed from both rural and urban areas in Tamil Nadu, using a structured interview schedule. The aim was to find out the perceptions of the patients about the PPs, the factors responsible for choosing them and discontinuing the treatment. The choice of PPs was influenced in both periods by accessibility (44 %vs41%), convenient timings (47% vs10 %;p<0.001), personal care (41%vs19%;p<0.001), known doctor(6%vs28%), confidentiality(19%vs9%;p<0.05) and dissatisfaction with government facilities (6% vs 10%). The single most important reason for discontinuation of treatment with the PP was financial problems (84% vs 63%). Patients who discontinued treatment due to financial reasons were willing to continue treatment with the PPs if the drugs were provided free of cost in NTP period where as after implementation of RNTCP, patients were willing to continue the treatment with public providers (15%vs84%). RNTCP gained in terms of convenience, personal care, and confidentiality from patients. Hence the involvement of PPs is essential to strengthen the programme .

3. Perceptions of HIV positive individuals on disclosure of their HIV status to their children.
Principle Investigator: Dr Beena E Thomas, Ms Chandra Suresh

There is some evidence that HIV disclosure although it serves as a stressor, facilitates emotional support which may lead to more effective coping and enhanced psychological adaptation ( Holt et al).However the potential for social stigma may inhibit people living with HIV/AIDS (PLWHAs ) from disclosure.

With the introduction, of ART and the need for life long treatment, HIV infected parents are faced with the biggest challenge on how to disclose their HIV status to their children. It is against this background that this cross sectional study is being carried out covering PLWHAs attending the out patient TRC clinics in General hospital and Chetpet after obtaining their consent. So far 75 patients have been recruited. The study is ongoing.

4. Community-Based Approach to Designing an AIDS Program for HIV+ Mothers in India(MLH)-Collaborative     study with the UCLA- University of Los Angeles
     Principle Investigator: Dr. Beena E. Thomas
     Source of funding: Indo-US joint working group on Maternal Health

MLH in India have little autonomy or decision-making power, are illiterate, and are unemployed. T he goal of this study is to gain an understanding of the perceived strengths manifested by MLH in India and life challenges they face in dealing with HIV/AIDS . In addition, we seek to learn about the format in which MLH would like to receive a future intervention program. These findings will result in a future proposal aimed at developing a culturally tailored intervention that will be appropriate for the physical and emotional needs of MLH and their children. The impact of this future intervention will subsequently be tested in a randomized clinical trial with MLH in Chennai, India.

The first phase of this study is a qualitative study using focus group discussions among MLH with children between the ages of 0-10. We have completed 10 focus Group Discussions among MLH covering 60 MLH thus far. We also plan to do in-depth interviews to get a wider perspective. This formative approach will help us to plan intervention strategies that are focused on the physical and mental health challenges of MLH

5. A study on sexual behaviour among sero discordant individuals.
Principle Investigator: Dr. Beena E. Thomas

There is dearth of information in India on sexual behavior and sexual risk factors among HIV sero discordant couples. This qualitative study aims to explore sexual behaviour patterns among serodiscordant individuals. In-depth interviews were conducted among eligible patients after obtaining their consent. Patients were recruited from outpatient clinics of TRC and TRC subcentres at Government hospital and Vellore. The findings of this study could help understand the sexual behavior patterns and sexual risk factors for HIV transmission which could be useful for health care providers in dealing with this group of individuals. So far 70 interviews have been conducted. The study is ongoing.

6. Attitude towards sex and sexuality among seropositive widows who lost their husbands to HIV/AIDS
Principle Investigator: Dr. Beena E. Thomas

It is widely recognized that infection rates among HIV infected women are on the rise. Furthermore the virus has left many young women in the age group of 18-40, widows who have lost their husbands to AIDS. Sex and issues related to sexuality are seldom addressed among this group of women who are at a vulnerable age. This cross sectional study is being carried out to understand the sexual behavior issues among HIV positive widows. The findings of this study would help highlights some of these issues that haunt young HIV positive widows which need to be addressed by health provider dealing with HIV/AIDS care. The study is ongoing.

7. Parental and care givers perceptions on disclosure of HIV diagnosis to sero positive children
Principle Investigator: Mrs. Meenalochani Dilip

One of the most difficult challenges for health providers dealing with HIV/AIDS is in dealing with seropositive children. The challenges vary from diagnosis, administering drugs, nutrition and most of all disclosure issues. This includes how and when to disclose, whether to disclose, who needs to disclose and how to deal with the problems related to disclosure. It is in order answer these questions that this study is being done as part of a clinical observational pediatric study done at the TRC.

Sero positive children are referred to the TRC clinics from various government hospitals, institutions and NGOs dealing with children. The children are accompanied by either their parents or care givers depending on where they come from. The respondents for this study were the parents or the care givers enrolled to the study after obtaining their consent. A semi structured interview schedule was used to elicit data. The study is ongoing.

8. A study on quality of life among HIV/TB patients on ART
Principle Investigator: Dr. Beena E. Thomas

This study is part of a controlled clinical trial to evaluate the safety and efficacy of two different once daily ART regiments along with ATT in patients with HIV-1 and TB. All patients enrolled to this study are considerable eligible if they consent to being a part of the study. The WHO - QOL BREF questionnaire is used to measure quality of life at 0, 1 year and 2 year intervals. The study will throw light on factors that influence QOL among HIV/TB patients on different regimens of ART. So far 47 patients have been enrolled. The study is ongoing.

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
Principle Investigator: Mrs. Niruparani Charles

The TB control programme is based on passive case finding. It is therefore crucial to understand the care seeking behavior of chest symptomatics to understand how they respond to their symptoms, their first point of contact, delay in seeking care and problems faced if any. A study with this objective was carried out prior to the RNTCP by the TRC. One of the main findings of this study was that the first point of contact was a private health care facility and the patient shifted to other facilities when dissatisfied. After the implementation of the RNTCP and the accessibility and availability of drugs at public health facilities we expect that there would be a change in the care seeking behavior patterns of chest symptomatics. It is against this background that this study has been planned. The aim of this study is to find out the care seeking pattern of the persons with chest symptoms after implementation of the RNTCP. This study will be conducted in two urban and two rural communities in Tamilnadu, South India. Households will be selected from the randomly selected streets. The heads of the selected households will be contacted to find out the presence of persons with chest symptoms. It is proposed to cover a total of 600 symptomatics, 150 in each of the four communities.

10. Psycho- social dysfunction: perceived and enacted stigma among tuberculosis patients under Revised National
    Tuberculosis Control Programme (RNTCP)
    Principal Investigator: Mrs. Jagarajamma
    Funding: Indian Council of Medical Research

Stigma and ostracism have been associated with chronic illnesses like leprosy, mental illness, tuberculosis (TB) and HIV/AIDS. TB carries a social stigma due to the perceived consequences of the infection. Understanding patient's perceptions about social stigma will enable health providers to help patients cope up with illness. We interviewed 276 TB patients registered for treatment during January-March 2004 in government health facilities of two Tuberculosis Units (TUs) of south India, in both rural and urban at one time point. Data on perceived and enacted stigma were collected after two months of starting treatment, using a semi- structured interview schedule. In addition four Focus Group Discussions (FGDs) were conducted among DOT providers and community members. Narrative summaries were also taken down to collect additional qualitative information. Of the 276 patients, 190 (69%) were males. There was no significant difference between the genders in relation to social stigma. Perceived stigma was higher than enacted stigma in both genders and significantly higher among males (Low self esteem p<0.05), change of behavior of community (p<0.05), ashamed to cough in front of others (p<0.05). Issues addressing key aspects of family life and social interactions should be discussed with patients prior to start of treatment to minimize stigma. Considering the social and emotional impact of the disease it is essential to adopt support strategies to enhance acceptance and for a successful health programme.

Biomedical Informatics Centre

Biomedical Informatics Centre (BIC) has been setup at Tuberculosis Research Centre, Chennai by Indian Council of Medical Research (ICMR) for

Further understanding of TB and HIV/AIDS by computational approach
To provide bioinformatics facilities to the Scientists and Research students and also extend the research facilities in Bioinformatics to other academic institutions and industries
For imparting skills in bioinformatics by organizing training programs/workshops for generating human resource

Facilities

Hardware:

Linux Server with Xeon Dual Processor, 2 GB RAM, & 5X72 GB Hard Disk - HP Desktops with Pentium IV processors with 1.25 GB RAM – 4 nodes

Software:

Discovery Studio – a complete package for Protein Modeling, Simulation and Interaction studies

CG – a comprehensive Sequence Analysis package

Epidemiological Research | Clinical Pathology | Immunology | Bacteriology | Statistical Studies