Medical Student Research Fellowship for Summer 2006

Mentor: Mamta K. Jain, M.D., M.P.H.
Department: Internal Medicine
Room number: Y7.312
Mail Code: 9113
Phone number: 214-648-9914
E-mail: mamta.jain@utsouthwestern.edu
Project title: Five Year Survival Analysis among HIV-infected Cohort : Analysis of Impact of Hepatitis B and C

Human subjects IRB approved project number (where applicable): IRB#1200-578

Animal subjects IRB approved project number (where applicable): n/a

Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects) patient-based reserach

Brief Description of Project:
Background: Since the introduction of highly active antiretroviral therapy (HAART), the number of patients dying from AIDS has dramatically decreased. Improvement in mortality has also occurred because of prophylaxis against pneumocystis pneumonia and mycobacterium avium. However, increasing deaths are being seen from other disease processes such as viral hepatitis, cardiovascular disease, and malignancies. Furthermore, in indigent populations, mortality from opportunistic infections (OIs) such as PCP continues to be the leading cause of death. We propose to examine the risk of death in a well characterized cohort of 1547 HIV-infected patients who are 25% co-infected with HCV and 8% co-infected with HBV. We will also examine the cause of death, if available, to determine the proportion of deaths due to OIs, liver disease, malignancies, cardiovascular or other causes.

Methods:
Database: In August 2000, all patients who had a clinic appointment were enrolled in a database. A patient was included regardless of whether he came for his clinic appointment. Medical records were reviewed for demographics, baseline CD4 cell count, HIV viral load, liver function tests, anti-HCV, and HB surface antigen, and alcohol consumption, and risk factors for HIV acquisition. Data on HIV medications from 1995-2003 were collected.

Part 1: Risk of death by baseline characteristics:
We plan to determine the number of patients who have died since August, 2000 by using a nationwide death registry. After identification of the patients reported to have died, we will examine the medical records of the patients to determine the most likely cause of death.
Part 2: Cause of death
Medical records will be reviewed of the patients who died at Parkland Hospital. For patients who died elsewhere, death certificates will be requested to determine cause of death.
Patients will be classified to have died from an OI, if they had the diagnosis of PCP, MAI, cryptococcus, histoplasmosis, cytomeglovirus, toxoplasmosis, or Microsporidia/isosporidia. Other infections include: tuberculosis, staphylococcus bactermia, streptococcus pneumoniae, and other gram negative and gram positive organisms. Viral hepatitis includes: death due to complications from chronic liver disease in someone with hepatitis B or C. Cardiovasular death includes patients who died from MI or other cardiac disease but not due to endocarditis. Patients who died due to a malignancy would be classified as such and would include both AIDS-related and non AIDS-related malignancies. Others includes suicide or accidents.

Analysis:
Part 1: Kaplan-Meier methods will be used to construct survival curves for the following groups:CD4 <200 cells/?L and >200 cells/?L; HCV+, HBsAg+, HCV and HBsAg+. Cox proportional hazards regression model will be used to determine variables associated with survival.

Part 2: Comparison of proportion of deaths due to OI compared to liver disease; AIDS-related to non AIDS-related, OIs compared to viral hepatitis, cardiovascular, non-AIDS malignancies, and other infections. Chi-square test will be used to compare proportions.

Previous Research Activities or Publications with Medical Students:
Rathi Pillai, summer 2004. Project she worked on is being prepared into a manuscript for submission and was presented a the national HIV meeting this year.

Jain M, Osuagwu C, Opio C, Pillai R, Keiser P, and Lee W. HIV Providers Neglect to Monitor for Hepatitis B Therapy Responses in HIV/HBV Patients Treated with HAART. 13th Conference on Retroviruses and Opportunistic Infections. Denver, February 5-9, 2006.

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