Meeting Minutes - April 19, 2007

Office of AIDS Research Advisory Council 
Twenty-Fourth Meeting
April 19, 2007

National Institutes of Health
U.S. Department of Health and Human Services
5635 Fishers Lane Conference Center
Rockville, MD

Members Present: Dr. James W. Curran (Interim Chair), Dr. Arlene D. Bardeguez, Dr. William A. Blattner, Dr. Coleen K. Cunningham, Dr. Isaac Delke, Dr. Sharon E. Frey, Dr. John H. Kempen, Dr. Judith A. Levy, Ms. Lynn Paige Nestor, Dr. Merle A. Sande, and Dr. Michael F. Summers

Ex Officio Members: John T. Brooks (for Dr. Kevin Fenton), Dr. Ronald O. Valdiserri, Dr. J. Brooks Jackson, Dr. Moon Shao-Chuang Chen, Jr., Dr. Ellie E. Schoenbaum, Dr. Carl W. Dieffenbach, and Dr. John G. Bartlett

Speakers: Dr. Richard Ambinder, Dr. Victoria A. Cargill, Dr. Steven Grinspoon, Dr. Carl Grunfeld, Dr. Andrea A. Howard, Dr. Priscilla Hsue, Dr. Jens D. Lundgren, Dr. Phyllis C. Tien, and Dr. Robert Yarchoan

Welcome and Meeting Overview

The NIH Office of AIDS Research Advisory Council (OARAC) convened its twenty-fourth meeting at 9 a.m. at the National Institutes of Health (NIH) in Rockville, Maryland. .Dr. James W. Curran, Interim Chair, welcomed the OARAC members, invited speakers, and guests to the meeting.

The topic of the meeting was “HIV-Related Complications—Malignancies, Cardiovascular Disease, and Metabolic Complications.” During the meeting, invited speakers discussed studies and findings in each of these areas, and the OARAC members had the opportunity to ask questions about the research.

The minutes of the October 25, 2006, OARAC meeting were approved as submitted. The OARAC members were asked to read and sign the conflict of interest form.

Director’s Report

Dr. Jack Whitescarver, Director of the NIH Office of AIDS Research, began his report by thanking Dr. Curran for serving as Interim Chair of the Council and welcomed a new OARAC member, Ms. Lynn Nestor, to the Council. Ms. Nestor is Founder and Executive Director of Steppin’ Up, Movin’ On, Inc., a community-based organization that provides HIV/AIDS counseling and testing to adjudicated youth in Washington, D.C. Dr. Whitescarver announced that Drs. Delke, Levy, and Sande will complete their OARAC terms before the next meeting and thanked them for their generous service to the Council. He reported on NIH personnel changes. Dr. Zerhouni recently appointed two new IC Directors – Dr. Barbara Alving as the Director of the National Center for Research Resources, and Dr. Griffin P. Rogers as the Director of the National Institute of Diabetes and Digestive and Kidney Diseases.

Dr. Whitescarver reported that the fiscal year (FY) 2008 NIH Trans-NIH Plan for HIV-Related Research has been completed. It has been distributed to OARAC members and is accessible on the web for the scientific community and public. The FY 2009 planning process is well underway. He presented the President’s budget for NIH AIDS research from FY 2003 to FY 2008, reflecting the impact of inflation on the budget. He also presented funding broken down by the Scientific Areas of the Strategic Plan, noting that the budget was increased slightly under the FY 2007 joint resolution. The budget was developed to provide support to the overall priorities in prevention research, including vaccines, microbicides, and behavioral interventions. Any additional funds in the NIH AIDS budget will be targeted for this important area of AIDS research. He noted that the FY 2008 appropriations hearings have been held.

Dr. Whitescarver underscored the invaluable advice provided by OARAC in ensuring that AIDS research dollars are distributed to the highest priorities. He emphasized that OAR is continuing to increase the focus on microbicide research at NIH. He and Dr. Fauci recently participated in a Congressional briefing on this area of research. OAR is currently recruiting for a health scientist administrator to lead a newly established microbicide section in OAR. A Microbicide Research Working Group is also being established to provide outside expert advice in this area. Dr. Mary Fanning has been detailed to OAR from the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), to lead activities in this area on an interim basis.

Dr. Whitescarver reported that a Joint Working Group (JWG) has been established as the focal point for the implementation of various elements of the U.S. – Indo Joint Statement on Collaboration on Prevention of Sexually Transmitted Diseases and HIV/AIDS. Several initiatives were launched this year under the auspices of the JWG by NIH including the issuance of a Program Announcement to support administrative supplements for collaborative prevention research between NIH grantees and collaborative scientists in India. A request for applications for collaborative research grants between U.S. and Indian investigators will be issued during the summer for funding in FY 2008. The goals of these activities are to strengthen the long-standing relationships between the U.S. and Indian biomedical research communities; further develop crucial research infrastructure and capacity building; and accelerate the translation of critical research findings into public health programs to prevent further spread of the pandemic. Dr. Whitescarver also noted that he had just returned from China, and that the Chinese and U.S. governments are actively working on furthering collaborative efforts in the area of AIDS research. He noted that there is support at high governmental levels in China for additional HIV/AIDS research.

Dr. Whitescarver provided an overview of the topic of the meeting today. It follows discussions from the last OARAC meeting on the restructured NIAID clinical trials networks which cited the need for broader trans-IC collaborations, particularly to focus more attention on the current HIV co-morbidities and complications and to consider the best mechanism to incorporate these new challenges into our research agenda, identifying scientific opportunities and gaps in these areas. The meeting today is structured to address AIDS-related malignancies, cardiovascular complications, and metabolic disorders that are the most common co-morbidities at this time. It is unclear whether these new complications are solely the result of new therapies, or whether they are the result of the disease itself. The agenda also addresses some important elements for consideration. For example, we also need to better understand the potential role that gender or race may play in these new complications. As OARAC has previously addressed HCV and other co-infections, we have not included those issues in our discussion today. Dr. Whitescarver stated that the epidemic continues to evolve, and we look to OARAC to provide advice and guidance in continually assessing our programs to ensure that they are responsive to the current needs and challenges before us.

Dr. Curran noted that with antiretroviral therapy many HIV-infected individuals in the U.S. and Western Europe are living longer today and this provides an opportunity to better understand the complications of therapy and long-term HIV infection. He commented that it is encouraging to observe the significant benefits research has had for many people living with HIV.

AIDS-Related Malignancies

Dr. Robert Yarchoan, National Cancer Institute (NCI), described emerging epidemiologic trends of AIDS-related malignancies, and presented an overview of the NCI Intramural AIDS research program. He noted that NCI first began conducting AIDS research over 25 years ago when the first reports of Kaposi’s sarcoma (KS) appeared in gay men. The initial research to identify the causative agent of AIDS was part of the NCI-sponsored studies focusing on viral causes of cancers.

Dr. Yarchoan reported that a significant component of NCI’s intramural research programs focused on drug screening, discovery, and development of antiretroviral agents. These programs led to the successful development and licensing of zidovudine (AZT), didanosine (ddl), and zalcitabine (ddC) as the first anti-HIV drugs. The drugs also later served as the backbone, when combined with protease inhibitors or non-nucleoside reverse transcriptase inhibitors, of highly active antiretroviral therapy (ART). While the number of persons living with AIDS in the U.S. has doubled since the introduction of ART, this now represents a new paradigm in terms of tumors. In addition to the AIDS-defining malignancies observed early during the epidemic, including KS, high-grade non-Hodgkin’s lymphoma, and cervical cancer, increasing numbers of other malignancies (e.g. Hodgkin’s lymphoma and lung cancer) are now being reported in HIV-infected individuals in the ART era. Several recent studies report that malignancies are the most frequent single cause of death in AIDS patients at this time.

Dr. Yarchoan projected that the number of people with both HIV/AIDS and cancer will continue to increase, presenting complex treatment and care challenges. He observed that cancer incidence will be impacted both by long-term survival among people using ART and by aging. The identification of appropriate treatment regimens for these patients will be hampered by the fact that HIV-infected patients have been generally excluded from cancer clinical trials in the past.

Dr. Yarchoan also described the research programs in NCI’s Division of Cancer Epidemiology and Genetics and the Center for Cancer Research. He reported on some of the projects that his own laboratory is conducting, including studies on the treatment of KS in AIDS patients. Other intramural programs are focusing on non-Hodgkin’s lymphoma in AIDS patients, primary effusion lymphoma, and mother-to-child transmission of KSHV.

Dr. Yarchoan described the NCI’s AIDS Malignancy Program that includes investigator-initiated research on AIDS-associated malignancies, the AIDS Malignancy Consortium, and educational and training activities. He reported on collaborative partnerships with AIDS initiatives in other Institutes, Centers, and Offices and the leveraging of capacity for AIDS-associated clinical trials with the newly restructured clinical trials networks.

Dr. Richard Ambinder, Johns Hopkins University, described some of the AIDS-related malignancies seen in the U.S. and worldwide. He noted that while the role of HIV in KS has been described, its role in other malignancies, such as lung cancer, is less clearly understood. He observed that most cases of Epstein-Barr virus (EBV)-associated malignancy in the United States are in HIV-infected patients. He also described epidemiological and clinical studies demonstrating an increase of Hodgkin’s disease in HIV-infected patients and the frequent occurrence of post-transplant lymphoma associated with HIV infection.

Dr. Ambinder commented that classic EBV malignancies are very different in their pattern of viral gene expression. These malignancies include post-transplant lymphoma, nasopharyngeal carcinoma, and Burkitt’s lymphoma. He noted that observations about pathogenesis may be relevant to studies on the future of lymphomagenesis in the HIV infected population. Dr. Ambinder also reported that there has been an increasing incidence of EBV-related Hodgkin’s disease in persons with HIV infection, possibly because of prolonged survival, moderate immunosuppression, and other cofactors. These findings have clinical impact because survival in patients with Hodgkin’s lymphoma is lower in HIV-infected patients.

Dr. Ambinder stated that AIDS-related malignancies are a leading cause of death in all regions of the world. He noted that clinical management of these HIV-related malignancies cannot be simply extrapolated from the extensive knowledge base of cancers in HIV-uninfected individuals. He proposed that resources are needed to develop appropriate mechanisms to capture data on the clinical management and outcomes of HIV-related cancers.

Several OARAC members commented that all of the studies described in the presentation involved adult subjects, but there is a large number of malignancies in children worldwide. They suggested that future research, including treatment trials, should address the manifestations in HIV-infected pediatric populations. They suggested that such studies could be conducted using the existing research infrastructure in Nigeria, which has a large cohort of HIV-infected individuals. One of the gaps that should be addressed is the need for infrastructure and research capacity in the U.S. and internationally to make diagnoses and collect specimens to assess the nature of HIV-related malignancies. Investigator-initiated opportunities or fast-track mechanisms in the clinical trial networks could be useful to conducting these studies in developing countries. The OARAC members commented that it is important to discuss research on HIV-related malignancies in the context of other scientific priorities in developing nations and the United States.

HIV-Related Cardiovascular Disease

Cardiovascular Disease in HIV-Infected Patients

Dr. Steven Grinspoon, Massachusetts General Hospital and Harvard Medical School, presented an overview on HIV-related cardiovascular complications. He stated that as HIV-infected patients live longer, there is evidence of increasing metabolic abnormalities, including insulin resistance, dyslipidimia, visceral adiposity, and loss of abdominal and peripheral subcutaneous fat. These changes are seen most often, but not exclusively, in the context of ART. He commented that cross-sectional MRI images have shown that HIV-infected patients, compared with control subjects, have a thinning of beneficial subcutaneous fat and an increase in deep visceral fat, which is associated with cardiovascular disease (CVD). The proportion of HIV-infected patients with abnormal fat distribution varies, but overall a majority of these patients demonstrate some abnormalities. Dr. Grinspoon noted that there is significant debate in the field about how to define lipodystrophy.

Dr. Grinspoon described a case control study conducted with the Framingham Offspring Study. The findings showed that in HIV-infected individuals, there was a relative increase in central adiposity, a significant increase in triglycerides and high-density lipoprotein (HDL) levels, compared with uninfected controls, and a higher prevalence of diabetes mellitus and impaired glucose tolerance. He commented that several potential factors may contribute to increased CVD risk associated with HIV disease. He noted that this risk can be assessed through calculated risk, actual risk, or surrogate markers.

Dr. Grinspoon described a study by his research group that looked at the incidence of myocardial infarction (MI) and risk factors in HIV-infected patients. He noted that differences were found in rates of hypertension, diabetes, and dyslipidemia for HIV-infected versus uninfected patients. These factors explain some, but not all, of the increases in risk in HIV-infected patients. He also reported that MI rates in California’s Medicaid population are higher for HIV-infected than uninfected patients, particularly among women. He observed that there is an emerging consensus that there is a greater risk of MI in HIV-infected patients, although the basis for this has not been defined.

Dr. Grinspoon described several surrogate markers for assessment of CVD risk in HIV-infected individuals including carotid intimal medial thickness (IMT). Studies have shown an increase in the IMT in HIV-infected individuals compared with a control group. He also stated that metabolic treatment strategies for HIV-associated lipodystrophy include lipid-lowering drugs, lifestyle modifications, insulin-sensitizing regimens, and approaches to changing fat redistribution.

Dr. Grinspoon reported that HIV-infected patients receiving ART demonstrate a number of metabolic changes, including insulin resistance, dyslipidemia, and fat redistribution. While these changes place some individuals at increased risk for heart disease, a number of therapeutic strategies exist to potentially modify this risk.

Dr. Priscilla Hsue, University of California, San Francisco, and San Francisco General Hospital, discussed HIV and CVD, with a focus on atherosclerosis and HIV surrogate markers. Her presentation described HIV and coronary artery bypass grafting (CABG)/percutaneous transluminal coronary angioplasty (PTCA), the pathogenesis of increased risk, and HIV and pulmonary hypertension. She noted that CVD is increasingly common in HIV-infected individuals. HIV is regarded as an independent risk factor for coronary disease. She commented that the pathogenesis of HIV-associated CVD remains unknown. She described several scientific needs, as well as future directions for research on HIV-related CVD, including studies on the mechanisms that result in increased cardiovascular risk in these individuals.

Dr. Hsue presented several cases from San Francisco General Hospital’s HIV Cardiology Clinic that measured carotid artery IMT using ultrasound as a gauge for atherosclerosis. She stated that IMT is an excellent predictor of MI and stroke. She noted that HIV-infected individuals have greater IMT and accelerated progression of IMT compared with uninfected controls, and that HIV infection is an independent predictor of higher IMT.

Dr. Hsue also described other cardiovascular manifestations of HIV disease, including: an increased rate of fatal or nonfatal CVD in patients using intermittent ART versus continuous ART; endothelial dysfunction; atherosclerosis; higher carotid IMT; higher incidence of thrombotic complications; and acute coronary syndromes at an early age.

The OARAC members proposed that more research is needed on: 1) the role of visceral fat associated with CVD; 2) stigma and mental health effects of HIV-related fat and facial wasting; and 3) differences in HIV-related CVD in racial and ethnic minority populations.

HIV-Related Metabolic Complications

Metabolic Diseases in HIV: Complications of HIV or ART?

Dr. Jens D. Lundgren, Copenhagen HIV Programme and University of Copenhagen, discussed metabolic diseases in HIV-infected individuals and whether these metabolic complications stem from HIV disease or ART. He highlighted the importance of identifying all of the relevant risk factors associated with these complications and delineating the effects of drug and non-drug factors that can impact these outcomes. He described the risk factors for some metabolic diseases associated with HIV disease including CVD, diabetes mellitus, hypertension, and lipoatrophy. He commented on the NIH-sponsored Strategies for Management of Antiretroviral Therapy (SMART) study that examined non-opportunistic disease outcomes when using continuous versus intermittent ART. He summarized the findings from the SMART study that demonstrated that CVD was seen more frequently with intermittent therapy than in those individuals on continuous therapy.

Dr. Lundgren also presented data from other studies that showed: individuals with low CD4 cell counts have a 12-fold increased risk of dying of liver related disease; certain anti-HIV drugs are associated with an increased risk of diabetes mellitus; and patients on antiretroviral therapy had an improvement in glomerular filtration rates over time.

Dr. Lundgren summarized by stating that multiple organ-specific manifestations, that traditionally have not been considered opportunistic diseases, are seen frequently with HIV disease, and that these are mostly due to metabolic changes. He noted that certain antiretroviral drugs increase the risk of some of these manifestations. He also commented that emerging data suggest that immunodeficiency, and lack of the use of ART, may accelerate some pathologies, including renal disease and liver disease. He proposed that future studies are needed to better elucidate the risks and benefits of earlier initiation of ART. He suggested that a randomized trial of early versus deferred treatment in patients with early HIV infection could help to define these risks and benefits of treatment and the influence of untreated HIV disease on a variety of pathologies. He commented that the findings from these studies would be useful for the clinical management of HIV disease, as well as impact other areas of medicine.

Dr. Carl Grunfeld, University of California, San Francisco, and San Francisco Veterans Affairs Medical Center, described several lipid disorders caused by HIV infection and/or treatment regimens, as well as the implications of such disorders in atherosclerosis. Abnormalities in lipid metabolism are observed frequently in HIV-infected individuals, but the causes of these disorders are multi-factorial and may include HIV infection, use of antiretrovirals, and changes in adipose tissue. He described the decrease in high-density lipoproteins (HDL) shortly after HIV infection with a limited decrease in low-density lipoprotein (LDL). With progression to AIDS, he noted that there is an increase in very low-density lipoprotein (VLDL) cholesterol. Dr. Grunfeld noted that high viral load is associated with abnormal lipid levels and that ART would improve these levels. Earlier studies showed protease inhibitors increased triglyceride levels. He commented that there is a need to delineate the effects of various drugs, changes in body composition, lipid abnormalities, and other variables. He subsequently described several studies designed to look at these factors.

Dr. Grunfeld commented that it is difficult to determine whether these metabolic disorders are the direct result of protease inhibitors (PIs) or are secondary to a reactivated immune system or body composition changes. While previous studies using PIs in uninfected individuals showed no change in body composition, some of the anti-HIV drugs did affect triglycerides and lipoprotein profiles. He suggested that increased LDL is not a drug effect, while increased triglyceride levels are drug-specific. He proposed that further research is needed to identify treatments for hypertriglyceridemia.

Dr. Grunfeld noted that HIV infection is accompanied by pro-atherosclerotic changes in lipoproteins, and that many of these changes are not improved with ART. Individual antiretroviral drugs induce different changes in lipids and lipoproteins—some are pro-atherosclerotic and some may protect individuals from atherosclerosis. He suggested that an outcome study was needed to examine end-stage complications of HIV disease.

Dr. Andrea A. Howard, Albert Einstein College of Medicine and Montefiore Medical Center, noted that the prevalence of diabetes has increased in the ART era. The Community HIV/AIDS Mobilization Project (CHAMPS) study has shown an increase of diabetes from 3 to 18 percent among middle-aged HIV-infected men who use PIs. She suggested that research is needed on diabetes, pre-diabetes, and insulin resistance as these are risk factors for CVD. She noted that ART can increase the risk of diabetes, and the presence of pro-inflammatory cytokines and Hepatitis C virus co-infection can exacerbate this risk.

Dr. Howard described the evidence that PIs have a direct effect on glucose metabolism and discussed the mechanisms by which PIs may induce insulin resistance. She commented that PIs do not appear to have an effect on insulin signaling, but they do appear to differ in their effects on insulin sensitivity.

In addition, Dr. Howard described several studies that have shown nucleoside reverse transcription inhibitors (NRTIs) have an effect on glucose metabolism. She also reported on several studies that present evidence that lipodystrophy affects glucose metabolism and that peripheral lipoatrophy is an independent contributor to insulin resistance. She observed that traditional risk factors for diabetes are prevalent among HIV-infected individuals. She noted that there is evidence that hepatitis C virus co-infection affects glucose metabolism in HIV-infected individuals and that opiate use has been associated with insulin resistance, decreased insulin secretion, and diabetes.

Dr. Howard commented that glucose metabolism disorders are common among HIV-infected individuals and HIV-specific and traditional diabetes risk factors play a role. She suggested that as HIV-infected individuals age, the risk of diabetes and CVD will likely increase. She suggested that future research focus on: risk of progression from insulin resistance to impaired glucose tolerance to diabetes; genetic determinants associated with glucose metabolism in HIV-infected individuals; effects of new antiretroviral agents on glucose metabolism; and clinical management of glucose metabolism in HIV-infected individuals.

Update on OARAC Working Groups for Treatment and Prevention Guidelines

Dr. John Bartlett, Johns Hopkins University, provided an update on the activities of the OARAC Working Groups for Treatment and Prevention Guidelines. The five guideline panels are now under the auspices of this Council. Three of the Working Groups develop guidelines for the use of antiretroviral treatment for adults and adolescents; for pediatric infection; and for prevention of maternal-child transmission. Two of the working groups develop guidelines for the prevention and treatment of opportunistic infections. The latter two groups will soon be combined. He noted that the latest versions of all of the guidelines are available on the HIVinfo website (https://hivinfo.nih.gov/home-page). These guidelines are updated as new scientific findings become available. He commented that each Working Group includes two Co-Chairs, a NIH Executive Secretary (who serves as the NIH government official), and approximately 30 members including representatives from academic, scientific, and community constituency groups. Members serve 3-year terms with an option for a one-term renewal. The current guidelines are downloaded from the Web approximately 5,000 times per day. When newly revised guidelines are first available, they are downloaded about 10,000 times per day.

Dr. Bartlett reported that the Adult and Adolescent Antiretroviral Guidelines were updated most recently in October 2006. A complete revision of the Perinatal Guidelines is anticipated in mid-2007. The Pediatric Guidelines were most recently updated in October 2006. The Opportunistic Infection (OI) Prevention Guidelines were last updated in 2002, and the OI Treatment Guidelines were released in 2004. The OI Working Groups will be combined and they will develop a complete revision by the fall of 2007. Most of the Working Groups plan to have new versions of the Guidelines completed by late 2007 or early 2008. Dr. Bartlett also commented that slide sets of the guidelines are available on the Web through the AIDS Education and Training Centers supported by the Health Resources and Services Administration.

A member of the public encouraged the panels to consider processes that would provide greater transparency and community participation. Dr. Whitescarver explained the process for community participation.

Gender Issues

Dr. Phyllis Tien, University of California, San Francisco, discussed sex differences in HIV-related disorders of fat and metabolism. She noted that few studies have reported on sex differences in fat distribution and disorders in lipid and glucose metabolism associated with HIV infection. While studies have been conducted among men, she reported there is increasing evidence about fat and metabolic disorders in HIV-infected women. These findings show women were at higher risk than men for developing central lipohypertrophy alone or a combination of central lipohypertrophy and peripheral lipoatrophy. She also cited another study within the Women’s Interagency HIV Study (WIHS) cohort that found a higher risk of developing peripheral lipohypertrophy in HIV-infected women compared with uninfected women. Dr. Tien described several studies on sex differences in lipid and lipoprotein levels that demonstrated that HIV-infected men and women have higher triglyceride levels and lower LDL and HDL levels than controls. She commented that these studies indicate that there may be possible differences in antiretroviral therapy effects on lipid and lipoprotein levels between HIV-infected men and women. Dr. Tien also reported that fat distribution and metabolic disorders in HIV-infected men and women appear more similar than different.

Dr. Tien noted that there is limited data available on sex differences in metabolic disorders associated with HIV disease. Extrapolation of differences across cohorts of HIV-infected men and women is difficult, and close collaboration among cohorts is needed. She proposed that gender specific differences should be studied in HIV-infected individuals, and that this will require close collaborations across cohorts and clinical studies. In addition, she proposed that a better understanding of disorders of fat and metabolism across genders and among racial and ethnic populations is needed.

OARAC members discussed potential research questions relating to reproductive issues, particularly among adolescents, and the need for studies on gender differences in HIV-infected older adults.

Racial and Ethnic Minority Issues

Dr. Victoria A. Cargill, NIH Office of AIDS Research, presented two cases of patients she cared for at a Washington, D.C. inner-city clinic to illustrate the complications of HIV disease comorbidities and treatment in racial and ethnic communities. The first case was a 42-year-old African-American female with HIV infection, hepatitis B, and hepatitis C who was seen for hip pain. The patient also presented with thinning limbs, large abdomen, and hump on her back. The second case was a 35-year-old HIV-infected, African-American male with hypertension, shingles, hepatitis B, and hepatitis C. The Council members discussed these cases and the complex clinical management decisions required of clinicians caring for patients. OARAC members noted that these cases exemplified many of the health issues faced by HIV-infected African Americans, made more difficult by underlying societal issues and the stigma of testing for HIV infection. The Council members proposed a continued focus and increase in prevention research to address these issues.

Public Comments

Mr. Michael Petrelis, a member of the public provided a personal perspective on the clinical complications of HIV disease and ARV treatment, as well as their psychological and sociological effects within the community and on HIV prevention efforts.

Dr. Curran thanked Mr. Petrelis for providing this personal perspective to today’s important topic.

Adjournment

Dr. Curran thanked the speakers, OAR staff, and OARAC members for their participation in the Council meeting. Dr. Whitescarver thanked Dr. Curran for chairing the meeting.

Dr. Whitescarver reflected that the discussions throughout the meeting had been thoughtful and provocative. He plans to report back at the next OARAC meeting on the progress that was made on research in the areas discussed.

The meeting adjourned at 5:00 p.m. on April 19, 2007.

Signed:
/Jack Whitescarver, Ph.D./
Jack Whitescarver, Ph.D., Executive Secretary

/James W. Curran, M.D., M.P.H./
James W. Curran, M.D., M.P.H., Chair