Rajiv Gandhi University of Health Sciences s91

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE

Annexure II

PROTOCOL FOR REGISTRATION OF SUBJECT FOR

DISSERTATION 1. NAME OF THE CANDIDATE : Dr. MOBIN PAUL

ADDRESS : Post Graduate Student,

Department of Medicine St. John’s Medical College Hospital,

Bangalore: 560034

2. NAME OF THE INSTITUTION : St.John’s Medical College Hospital

Bangalore-560034.

3. COURSE OF STUDY AND SUBJECT: MD General Medicine

4. DATE OF ADMISSION TO THE COURSE : 17th March 2008

5. TITLE : PROFILE OF HIV/AIDS SEEN

IN OLDER ADULTS [≥50 years]

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

The Joint United Nations Programme on HIV/AIDS (UNAIDS) categorizes patients over the age of 50 yrs a separate category. It estimates that around 2.8 million adults aged 50 years and older are living with HIV, representing 7 percent of all cases. National AIDS Control Organization (NACO) categorizes people over the age of 50 years as a separate category. NACO estimates 7 % of HIV infected people are over the age of 50 years. For this study people ≥ 50 yrs of age will be considered keeping the NACO guidelines and UNAIDS guidelines.

As patients grow older, immune system will not function actively- it is hypothesized that patient in older age have higher incidence of AIDS defining illness and higher mortality. Their needs and problems are different when compared to that of young individuals. As people grow older, chances of co- existence of multiple co- morbidities like diabetes, hypertension, coronary artery disease, dyslipidemia will increase. These factors may influence the course and manifestations of HIV/AIDS. Polypharmacy among the older adults due to their preexisting co morbidities can influence the drug therapy.

There are few studies on ‘profile of HIV/AIDS in older adults’ in world literature. There are no reported studies from India. Hence, this study will address this gap. 6.2 REVIEW OF LITERATURE:

Epidemiological data from developed countries show that the HIV- infected population is ageing in parallel with the use of potent treatments, and that the number of older patients who are newly infected or newly diagnosed is increasing. Data from the CDC1 show that the cumulative number of AIDS cases among American adults over 50 years of age quintupled during the last decade; in 2000, patients over 50 accounted for 15% of all AIDS cases recorded in the United States2. The figures are similar in France: in 2003, 19% of patients enrolled in the French hospital database on HIV infected patients, were over 50years. Data from India shows 7% of people living with HIV/AIDS are aged above 50 years.

Data demonstrate that advanced age is associated with more rapid progression to AIDS. Caroline Sabin and COHERE study group suggesting that those over 50 years of age have better responses to HIV therapy than those who are younger – probably as a consequence of better adherence.3 CD4+ cell count and antibody responses are often blunted among older HIV-infected individuals. Number of studies suggest that HIV leads to a kind of immune system exhaustion. For example, premature shortening of the length of telomeres – has been demonstrated during HIV progression.4

Malignancy and cardiovascular diseases are age related and are more common among older HIV infected patients.5 HIV infected persons often have traditional risk factors for these diseases Smoking is highly prevalent among HIV- infected individuals6 and enhance risk for both cardiovascular diseases and many malignancies. HIV itself is increasingly being demonstrated to induce production of pro-inflammatory molecules that can hasten cardiovascular diseases. Although antiretrovirals can counter some of this viral-mediated inflammation, the effects of these medications may also exacerbate conditions

associated with aging, including reduced bone mineral density, diabetes and metabolic syndrome and cardiovascular diseases.

The available data do suggest that HIV infection leads to biological changes, especially within the immune system, that mimic premature ageing. Older patients are at a higher risk of HIV disease progression, for atleast three reasons: first, they tend to be diagnosed at a more advanced stage; second, they have a slower immunological response to HAART; and third, they are at a higher risk of complications, such as cancer and cardiovascular disease because of the combined effect of ageing, HIV infection and antiretroviral treatment.7

6.3 OBJECTIVE OF THE STUDY:

Primary objective

1. A. To study the prevalence of HIV among older adults admitted to medical wards of SJMCH.

B. To study the percentage of older patients among HIV infected adults.

Secondary objective

1 To study the prevalence of AIDS among HIV infected older adults.

2 To study the pattern of opportunistic infections and HIV associated malignancy in the study population. 3 To observe the association of various co-morbid conditions in this group of older adults.

4 Correlation between CD4 count and AIDS defining illness.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA

Location: Medical wards of St. John’s Medical College Hospital

Study period: 1st of September 2008 to 31st August 2009

Estimated number of subjects for proposed study : 30

Inclusion Criteria

 Patients (≥50 years) admitted to medical wards of SJMCH and diagnosed to have HIV infection according to NACO guidelines for serological diagnosis

Exclusion Criteria

 Patients who refuse consent.

7.2 Method of collection of data (including sampling procedure, if any) After obtaining informed consent, patients will undergo a detailed clinical examination according to the performa. Routine laboratory examination like blood routine, chest x-ray, liver function tests, renal function tests and CD4 count estimation will be performed. Presence of AIDS defining illness will be confirmed by applying NACO criteria.

A log book of all HIV infected patients admitted in the medical ward will be maintained and the opportunistic infection, malignancies and HIV related disease will be documented to fulfill the primary objective.

Statistical Data

The prevalence of HIV among the older patients admitted during the study period will be calculated.

Prevalence of older patients (≥50 years) among HIV infected patients admitted to the medical wards of the SJMCH will be calculated.

Among the older patients

Prevalence of AIDS

Patterns of opportunistic infections, Malignancies and co morbidities will

be calculated. Cd4 counts and its correlation with the opportunistic infections will be

asessed. Comparisons Between older adults(≥50 years) and younger individuals with HIV infection will be calculated based on

Patterns of opportunistic infections and AIDS related malignancies Data will be tabulated and epiinfo 3.8.4 august 2008 system will be used for analysis. 7.3 Does the study require any investigations or interventions to be conducted on patients or other animals? If so, please describe briefly.

Routine laboratory examination, CD4 count, chest x-ray will be performed.

Patient will undergo investigations necessary for the diagnosis of AIDS defining illness based on NACO guidelines.

7.4 Has ethical clearance been obtained from your institution in case of 7.3 Obtained.

8. List of References.

1.Centers for Disease Control and Prevention. AIDS cases in adolescents and adult, by age – United States,1994-2000.HIV/AIDS Surveill Suppl Rep 2003;9:1-24.

2. Mack K, Ory M. AIDS and older Americans at the end of the twentieth century. J Acquir Immune Defic Syndr 2003;33: s68-75.

3. Sabin C and Collaboration of Observational HIV Epidemiolological Research Europe (COHERE) Study. Response to combination ART: variation by age. Programme and abstracts of the 14th Conference on Retrovirus and Opportunistic Infections; February 25-28, 2007: Abstract 528.

4. Effros RB. Telomeres and HIV disease. Microbes Infect. January 2000; 2(1):69-76

5. Smith CJ, Levy I, Sabin CA, Kaya E, Johnson MA, Lipman MCI. Cardiovascular disease risk factors and antiretroviral therapy in an HIV- positive UK population. HIV Medicine. March 2004;5(2):88-92.

6. Hadigan C, Meigs JB, Wilson PWF. Prediction of coronary heart disease risk in HIV-infected patients with fat redistribution. Clin Infect Dis. April1,2003;36(7):909-916.

7. Grabar S, Weiss L, Costagliola D. HIV Infection in older patients in the HAART era. Journal of Antimicrobial Chemotherapy.2006;57:4-7. 9. SIGNATURE OF CANDIDATE:

10. REMARKS OF THE GUIDE:

11. NAME AND DESIGNATION OF:

11.1 GUIDE: Prof. G.D. Ravindran, M.D.

Dept. of Medicine,

St. John’s Medical College Hospital,

Bangalore – 560 034.

11.2 SIGNATURE

11.3 CO-GUIDE: Dr. Betsy Mathew, M.D.

Associate Professor,

Dept. of Medicine,

Bangalore – 560 034. 11.4 SIGNATURE: 11.5 HEAD OF DEPARTMENT: Prof. S.D. Tarey, M.D.

Head of the Department,

Dept. of Medicine,

Bangalore – 560 034. 11.6 SIGNATURE :

12.1 REMARK OF CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE :