Appendix B
Committee Charge

The Social Security Administration (SSA) charged the Institute of Medicine with completing a series of tasks and subtasks. This appendix serves as an index of the committee’s responses to each question throughout the report.


1. The Consensus Committee shall review, in a written report for the use of SSA, the most current medical literature to determine the latest standards of care, the latest technology for the understanding of disease processes, and the latest science demonstrating the impact of HIV infection on patients’ health and functional capacity. As part of the review, the Consensus Committee shall perform the following subtasks:


Subtask 1A: The Consensus Committee shall survey published scientific literature, research, and studies to gather available information on the current medical and functional status (both mental and physical) of the cohort of very young children who (1) became HIV infected between 1988 and 1996 (primarily perinatal transmission), and (2) received serial antiviral monotherapy prior to the introduction of highly active antiretroviral therapy (HAART)(circa 1996–1997).

The Consensus Committee shall survey published scientific literature, research, and studies to gather available information on the current medical and functional status (both mental and physical) of the cohort of very young children who (1) became HIV infected after 1996 and (2) have only received HAART therapy.

Specifically, the Consensus Committee shall compile a report based on



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Appendix B Committee Charge The Social Security Administration (SSA) charged the Institute of Medi- cine with completing a series of tasks and subtasks. This appendix serves as an index of the committee’s responses to each question throughout the report. 1. The Consensus Committee shall reiew, in a written report for the use of SSA, the most current medical literature to determine the latest standards of care, the latest technology for the understanding of disease processes, and the latest science demonstrating the impact of HIV infection on pa- tients’ health and functional capacity. As part of the reiew, the Consensus Committee shall perform the following subtasks: Subtask A: The Consensus Committee shall surey published scientific lit- erature, research, and studies to gather aailable information on the current medical and functional status (both mental and physical) of the cohort of ery young children who () became HIV infected between  and  (primarily perinatal transmission), and () receied serial antiiral mono- therapy prior to the introduction of highly actie antiretroiral therapy (HAART)(circa –). The Consensus Committee shall surey published scientific literature, research, and studies to gather aailable information on the current medi- cal and functional status (both mental and physical) of the cohort of ery young children who () became HIV infected after  and () hae only receied HAART therapy. Specifically, the Consensus Committee shall compile a report based on 4

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4 HIV AND DISABILITY the currently aailable information comparing the medical and functional status of both cohorts in order to determine if there is any medical or functional basis (either mental or physical) on which SSA would ealuate the impairments of each of these cohorts differently when adjudicating their disability claims at age  under the HIV Infection Listing (4.0) for adults. Response: Information regarding HIV-infected children’s medical and functional status can be found in Chapter 7. The incidence of perinatal infection has decreased greatly since the widespread use of antiretro- viral therapy and aggressive testing; currently around 15,500 children live with HIV/AIDS as a result of increased survival (CDC, 2009). Prior to 1997, perinatal survival was low. In 1997, combination antiretro- viral therapy became standard for treating children, leading to higher survival rates. As discussed in Chapter 7, children have benefited from advances in treatment in the same pattern as adults (McConnell et al., 2005). Combination antiretroviral therapy has resulted in reduced mor- tality, increased immune system functioning, and decreased complica- tions from comorbidities and opportunistic diseases. Despite advances, challenges occur because options for therapy have been reduced as a result of multiple-resistance mutations. Little high-quality literature compares children of the above mentioned cohorts, and the committee found no literature indicating the cohorts should be treated differently when adjudicating claims. Subtask B: The Consensus Committee shall surey published scientific literature, research, and studies to determine the following: • What published information (for example, medical and ocational literature) is aailable regarding the presence of chronic diarrhea in HIV-infected patients as an indicator of seerity (both prognosti- cally and functionally)? • How is chronic diarrhea in HIV-infected patients defined? • How is chronic diarrhea in HIV-infected patients documented? • What are the medical treatments for chronic diarrhea in HIV- infected patients? • How effectie is treatment for diarrhea in HIV-infected patients? • What is the association between chronic diarrhea in HIV-infected patients and HIV wasting syndrome? Response: The committee defined diarrhea as a change in an individ- ual’s stool pattern with ≥ 3 stools per day that are loose or watery for ≥ 3 weeks (see Chapter 5). In the literature, diarrhea is often defined by

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4 APPENDIX B stool weight (greater than 200–300 grams/day), by stool frequency and character (greater than two to three loose or watery stools/day), or by stool viscosity (Dieterich et al., 1994; Doumbo et al., 1997; Fanning et al., 1991). A review of 46 studies of HIV-associated diarrhea showed most investigators defined diarrhea by duration and stool count (see Table B-1) (Tinmouth et al., 2007). Relatively few studies address the problem of debilitating diarrhea associated with HIV and its treatment that reflect current experience. As a result, the committee found no literature regarding the presence of chronic diarrhea as an indicator of severity. Two reports deal with quality-of-life issues (Siddiqui et al., 2007; Tramarin et al., 2004), but both were conducted relatively early in the era of combination antiret- roviral therapy when diarrhea complicating treatment was more com- mon. For example, the Siddiqui et al. study (performed in New York City from 2001 to 2003) showed a significant difference in diarrhea rates due to protease inhibitor-based (PI-based) treatment at a time when the major agents used in that class (NFV, LPV/r) were associated with high rates of diarrhea. Nevertheless, the rate of diarrhea was still relatively high (17 percent) in patients receiving alternative agents. The more recent experience with the PI class of antiretroviral agents is shown in Table B-2, which provides results of comparative trials using standard definitions for diarrhea. These data emphasize the differences between agents in this class and the relatively low rates with more recently introduced agents. Occasional patients present with diarrhea reflecting late-stage HIV infection due to late HIV diagnosis or failed therapy. Possibly the most serious condition in terms of diarrhea is cryptosporidiosis with CD4 less than 50 cells/mm3 because this may cause devastating diarrhea that can be controlled only with immune recovery. Other late-stage conditions may cause severe diarrhea, including microsporidiosis, dis- TABLE B-1 Review of 46 Studies of Diarrhea Complicating HIV Infection Characteristic Number of Studies Comment Duration 33 (72%) Ranged from 1–6 weeks 21/33 ≥ 4 weeks 15/29 (52%) specified ≥ two stools/day and most used Stools/day 29 (63%) terms “loose” or “watery” Stool weight 10 (22%) 7/10 used > 500 grams/day SOURCE: Tinmouth et al., 2007.

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44 HIV AND DISABILITY TABLE B-2 Frequency of Diarrhea in Clinical Trials Using Protease Inhibitor-Based Therapy LPV/r Comparator Study N % N % KLEANa 443 11 FPV/r 436 13 GEMINIa 168 14 SQV/r 163 7 M05-730a 331 15 LPV/r 333 17 ARTEMISb 446 11 DRV/r 343 4 CASTLEb 437 12 ATV/r 441 2 NOTE: aKLEAN, GEMINI, and M05-730 represent 48-week data; bARTEMIS and CASTLE represent 96-week data. SOURCES: Eron et al., 2006; Gathe et al., 2009; Mills et al., 2009; Molina, 2008. seminated Mycobacterium aium, and disseminated cytomegalovirus infection. The rates of these conditions are shown in Table B-3. As discussed in Chapter 5, diarrhea in people infected with HIV can often be treated with antibiotics, but may require combination an- tiretroviral therapy. These therapies are generally quite effective; some nonspecific therapies such as loperamide also have been successful. The literature is sparse about the current association between di- arrhea and HIV-associated wasting syndrome. HIV-associated wasting has been defined as the following: unintentional weight loss of greater than 10 percent, body mass index (BMI) decreasing to less than 20, and a rapid weight loss of greater than 5 percent in 6 months (Mangili et al., 2006). In 466 participants with HIV in the Nutrition for Healthy Living Cohort, 18 percent lost greater than 10 percent of their weight, 8 percent had a BMI less than 20, and 21 percent lost greater than 5 percent in 6 months. Every 1 percent increase in weight loss correlated to an 11 percent increase risk of death. Weight loss was attributed to TABLE B-3 AIDS-Defining Conditions That Often Present With Severe Diarrhea in the HOPS Cohort of 8,070 Participants Rate (per 1,000 patient years) Pre-HAART HAART Condition 1994–1997 2003–2007 Cryptosporidiosis 7.3 0.8 26.9 2.5 Mycobacterium aium Cytomegalovirus 33.0 1.8 NOTE: HAART = highly active antiretroviral therapy. SOURCE: Buchacz et al., 2010.

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4 APPENDIX B the following: (1) gastrointestinal dysfunction (malabsorption, AIDS enteropathy); (2) decreased dietary intake; (3) absence of HAART (leading to 0.9 kg reduction in body weight with each log increase in HIV viral load); (4) inflammatory cytokines, and (5) AIDS-defin- ing conditions contribute, but “are not a major cause.” It has been suggested that wasting should be defined by loss of body mass, with bioelectrical impedance measuring change in body cell mass (Wanke et al., 2004). Another study found weight loss and wasting to be im- portant comorbidities in patients receiving combination antiretroviral therapy, although the cause of weight loss was not determined (Tang et al., 2002). A longitudinal study of 1,474 HIV-infected patients showed that total body weight correlated directly with physical functioning, as reported by patients; specific weight reduction that would be disabling was not described (Wilson et al., 2002). Subtask C: The Consensus Committee shall surey published scientific literature, research, and studies related to the opportunistic infections, cancers, or other conditions described in the criteria of immune system disorders listing 4.0 for adults with HIV infection to determine the following: • How has the treatment of these related conditions changed recently? • How effectie are newer treatments for these conditions? • How aailable are newer treatments? • Are there indicators that these related conditions would preent the ability to do any work for a continuous period of at least  months? • Are there indicators that these related conditions would be ex- pected to result in death? Response: The rates of opportunistic infections and cancers have de- creased rapidly with widespread use of combination antiretroviral therapy. Chapter 2 described how opportunistic infections and cancers can continue to cause morbidity and mortality, but at much lower rates than at the beginning of the epidemic (Buchacz et al., 2010) (see Table C-1 in Appendix C). Some specific opportunistic infections, cancers, and other conditions can be expected to result in disability or death, as discussed in Chapters 4–6.1 In cases where opportunistic 1 Conditions discussed in Chapter 4 are HIV-associated dementia, multicentric Castleman’s disease, Kaposi’s sarcoma involving the pulmonary parenchyma, primary central nervous system lymphomas, primary effusion lymphoma, and progressive multifocal leukoencepha-

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4 HIV AND DISABILITY infections do occur, they would largely be captured by low CD4 count or limited functioning. Many opportunistic infections and cancers can now be prevented or treated with use of antiretroviral therapies. Some classes of antiretroviral therapies may induce development of cancers, but the literature in this area is inconclusive (Powles et al., 2009). No specific indicators were identified in the literature showing opportunistic infections and cancers would prevent one’s ability to work for a continuous period of at least 12 months or would result in death. The lack of indicators contributed to the development of the committee’s recommendations. Subtask D: The Consensus Committee shall surey published scientific literature, research, and studies related to the opportunistic infections, cancers, or other conditions described in the criteria of immune system disorders listing 4.0 for children with HIV infection to determine the following: • How has the treatment of these related conditions changed recently? • How effectie are newer treatments for these conditions? • How aailable are newer treatments? • Are there indicators that these related conditions would cause marked and seere functional limitations for a continuous period of at least  months? • Are there indicators that these related conditions would be ex- pected to result in death? Response: As discussed in Chapter 7, children have responded in similar patterns to combination antiretroviral therapy as adults (see response to Subtask 1C). The committee did not identify specific indicators of opportunistic infections, cancers, or other conditions that would lead to functional limitations or death in children. Subtask E: The Consensus Committee shall surey published scientific literature, research, and studies related to the coinfection of HIV infection and hepatitis to determine the following: lopathy. Conditions discussed in Chapter 5 are diarrhea, distal sensory polyneuropathy, HIV-associated neurocognitive disorders, HIV-associated wasting syndrome, Kaposi’s sar- coma, lipoatrophy or lipohypertrophy, and osteoporosis. Conditions discussed in Chapter 6 are cardiovascular disease, chronic kidney disease, diabetes, hepatitis, and malignancies not mentioned elsewhere in the report.

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4 APPENDIX B • Are there indicators that such a coinfection would preent the ability to do any work for a continuous period of at least  months? • Are there indicators that such a coinfection would result in death? Response: Infection with both HIV and hepatitis is a serious condition that can lead to chronic liver failure and potentially lead to death, but coinfection has not been found to be clinically distinct from hepatitis alone (see Chapter 6). No indicators were found suggesting coinfection as a primary reason why an individual would be prevented from work- ing for at least 12 months or would result in death. This finding led to the committee’s inclusion of hepatitis in Recommendation 5. Subtask F: The Consensus Committee shall surey published scientific literature, research, and studies related to the coinfection of HIV infection and chronic pancreatitis to determine the following: • Are there indicators that such a coinfection would preent the ability to do any work for a continuous period of at least  months? • Are there indicators that such a coinfection would result in death? Response: As discussed in Chapter 2, chronic pancreatitis is not as common in patients with AIDS largely as a result of didanosine and stavudine being no longer widely used in the treatment of HIV/AIDS. Since the widespread use of combination antiretroviral therapies, the incidence of pancreatitis has been similar for both HIV-infected and non-HIV-infected populations (Gan et al., 2003). Chronic pancreatitis is usually the result of recurrent episodes of acute pancreatitis that results in permanent damage to the pancreas. The most common cause of chronic pancreatitis is alcohol use and, as such, this problem is not confined to patients with HIV/AIDS. Symptoms of chronic pancreatitis include abdominal pain and chronic diarrhea that leads to malabsorp- tion. Patients can also develop diabetes. In patients with severe chronic pancreatitis, the diagnosis is easily made, but it is more difficult in early stages when endoscopic ultrasonography has been found to be quite sensitive. The differential diagnosis of chronic pancreatitis includes peptic ulcer disease, biliary tract disease and malignancy. Some HIV medications can increase the risk of developing pancreatitis, particu- larly the nucleoside reverse transcriptase inhibitor class of drugs and most notably didanosine and stavudine (Kahn et al., 1992; Moore et

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4 HIV AND DISABILITY al., 2001; Smith et al., 2008). However, other drugs commonly used in patients with HIV/AIDS such as rifampin and trimethoprim/sul- famethoxazole can also cause pancreatitis. The committee found no current indicators that coinfection would prevent ability to work for a continuous period of 12 months or result in death. 2. The Consensus Committee shall produce a written report for the use of SSA analyzing documents receied in response to SSA’s HIV Adance Notice of Proposed Rulemaking (ANPRM) request for public comment to determine which, if any, recommendations hae the potential to become indicators of disability as defined by SSA (that is, to assess which, if any, comments or recommendations would be useful in deeloping listing crite- ria for determining disability). Response: The committee considered all comments responding to SSA’s HIV ANPRM request. As discussed in Chapter 1, some of the responses were built on by the committee in the development of the report. For example, the committee recommended that HIV encephalopathy be broadened to include other neurocognitive conditions and added cen- tral nervous system lymphomas, both suggestions in response to the 2008 ANPRM. Other more specific responses (e.g., modifying “herpes zoster” to “herpes or varicella zoster”) were not seen to be as relevant to the report, given the current state of medical practice and the com- mittee’s reconceptualization of the HIV Infection Listings. 3. The Consensus Committee shall produce a written report for the use of SSA that compares and contrasts findings in the most current medical literature and ANPRM public comments with SSA’s current HIV listings, as well as the key concepts included in the introduction of the HIV listings. Response: The current 14.08 Listing consists, for the most part, of opportunistic infections. Many of these infections are proposed to be excluded from being named specifically in a revised listing because they are not as common or disabling as they once were, such as bacterial and protozoan or helminthic infections (see Table B-4). The commit- tee believes that claimants who are at significant risk of being disabled (i.e., those who were once at high risk for acquiring an opportunistic infection) would have at least one of the following: CD4 ≤ 50 cells/mm3; • • I mminently fatal or severely disabling HIV-associated conditions;

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TABLE B-4 Comparison of Current 14.08 Listing to Suggested Revisions Current Listing Suggested Revision Explanation 14.08A Bacterial infections Remove from Listing Bacterial infections themselves are no longer predictive of disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 14.08B Fungal infections Remove from Listing Fungal infections themselves are no longer predictive of disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 14.08C Protozoan or helminthic Remove from Listing Protozoan or helminthic infections themselves are no longer predictive of disability; infections claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 14.08D Viral infections Remove from Listing Viral infections are no longer predictive of disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 14.08E Malignant neoplasms Cross-reference to The current Malignant Neoplasms Listing is adequate to adjudicate claims of HIV- Malignant Neoplasms associated malignancies (13.00) 14.08F Conditions of the skin Remove from Listing These conditions are no longer predictive of disability; claimants experiencing or mucous membranes disability would qualify under low CD4 count or other categories of HIV-associated with extensive fungating conditions or ulcerating lesions not responding to treatment 14.08G HIV encephalopathy Revise to reflect “HIV-associated neurocognitive disorders” is the current term used current terminology 4 continued

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TABLE B-4 Continued 0 14.08H HIV wasting syndrome Retain as HIV- HIV-associated wasting syndrome can still be disabling if it impairs functioning associated comorbidity currently without listings elsewhere 14.08I Diarrhea Retain as HIV- Diarrhea can still be disabling if it impairs functioning associated comorbidity currently without listings elsewhere 14.08J Other infections Remove from Listing These conditions are no longer predictive of disability; claimants experiencing resistant to treatment or disability would qualify under low CD4 count or other categories of HIV-associated require hospitalization conditions or intravenous treatment 14.08K Other manifestations of Remove from Listing These conditions are no longer predictive of disability; claimants experiencing HIV infection disability would qualify under low CD4 count or other categories of HIV-associated conditions

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 APPENDIX B • HIV-associated condition without a listing elsewhere in the Listing of Impairments; and/or • HIV-associated condition with a listing elsewhere in the Listing of Impairments. Some conditions in the current 14.08 Listing should be retained because they can still cause disability. These include HIV wasting syn- drome (currently 14.08H) and diarrhea (currently 14.08I). Even when treated with combination antiretroviral therapy, these conditions con- tinue to cause disability as discussed in Chapters 4–6. Additionally, the committee suggests updating the HIV encephalopathy sublisting (currently 14.08G) to “HIV-associated neurocognitive disorders.” This suggestion reflects changes in the understanding of HIV’s effect on the brain. The current 14.08K sublisting considers repeated occurrences of a number of manifestations, some of which the committee believes con- tinue to present serious challenges for HIV patients, such as hepatitis and peripheral neuropathy. With respect to Part B (sublisting 114.08), similar suggestions were made to that of Part A, with three differences. First, the com- mittee concluded that neurological manifestations of HIV infection in children (currently 114.08G) still pose large challenges for children. Second, growth disturbance (currently 114.08H) continues to be a cause of severe disability in children. The committee suggests that both neurological manifestations and growth disturbance be retained as imminently fatal or severely disabling conditions. Finally, the com- mittee decided lymphoid interstitial pneumonia/pulmonary lymphoid hyperplasia (LIP/PLH) complex (current 114.08J) should be removed from the Listing. As discussed in Chapter 7, LIP/PLH complex is an HIV-associated disease with no known etiology and was commonly observed in HIV-infected children before the availability of combina- tion antiretroviral therapy. These suggestions are shown in Table B-5. 4. The Consensus Committee shall recommend eidence-based guidance that, if incorporated into the HIV listings, would improe their utility for ealuating disability claims based on the HIV listings. The Committee will take into account considerations regarding the applicability of their recom- mendations in the SSA disability program. Examples of such considerations are: () consistency with standard medical practice; () cost and nationwide aailability of any recommended tests; and () minimal risk and incone- nience to the claimant. Response: The committee’s principles for developing its recommenda- tions include feasibility and consistency with standard medical practice.

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TABLE B-5 Comparison of Current 114.08 Listing to Suggested Revisions  Current Listing Suggested Revision Explanation 114.08A Bacterial infections Remove from Listing Bacterial infections themselves are no longer predictive of disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 114.08B Fungal infections Remove from Listing Fungal infections themselves are no longer predictive of disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 114.08C Protozoan or helminthic Remove from Listing Protozoan or helminthic infections themselves are no longer predictive of infections disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 114.08D Viral infections Remove from Listing Viral infections themselves are no longer predictive of disability; claimants experiencing disability would qualify under low CD4 count or other categories of HIV-associated conditions 114.08E Malignant neoplasms Cross-reference to The current Malignant Neoplasms Listing is adequate to adjudicate claims of Malignant Neoplasms HIV-associated malignancies (113.00) 114.08F Conditions of the skin Remove from Listing These conditions are no longer predictive of disability; claimants experiencing or mucous membranes disability would qualify under low CD4 count or other categories of HIV- with extensive fungating associated conditions or ulcerating lesions not responding to treatment 114.08G Neurological Retain as severely Neurological manifestations of HIV infection continue to be disabling manifestations of HIV disabling condition infection 114.08H Growth disturbance Retain as severely Growth disturbances continue to be disabling disabling condition

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114.08I Diarrhea Retain as HIV- Diarrhea can still be disabling if it impairs functioning associated comorbidity currently without listings elsewhere 114.08J Lymphoid interstitial Remove from Listing LIP/PLH complex has been shown to be not disabling pneumonia/pulmonary lymphoid hyperplasia complex (LIP/PLH) 114.08K Other infections Remove from Listing These conditions are no longer predictive of disability; claimants experiencing resistant to treatment or disability would qualify under low CD4 count or other categories of HIV- require hospitalization associated conditions or intravenous treatment 114.08L Other manifestations of Remove from Listing These conditions are no longer predictive of disability; claimants experiencing HIV infection disability would qualify under low CD4 count or other categories of HIV- associated conditions 

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4 HIV AND DISABILITY The only test suggested in the recommendations is CD4 count, which is standard for HIV-infected patients and costs less than $50 per test, as discussed in Chapter 3. This will not inconvenience claimants or place them at risk, as CD4 is a standard part of care. 5. The Consensus Committee shall produce a written report for the use of SSA indicating what eidence, laboratory findings, and signs and symptoms within the medical eidence of record may improe the sensitiity and speci- ficity of the listing criteria to identify indiiduals who meet SSA’s definition of disability. 6. The Consensus Committee will produce a written report for the use of SSA with all of its findings. The report may be made aailable to the interested public only after the Task Order has ended. REFERENCES Buchacz, K., R. K. Baker, F. J. J. Palella, J. S. Chmiel, K. A. Lichtenstein, R. M. Novak, K. C. Wood, J. T. Brooks, and the HOPS Investigators. 2010. AIDS-defining opportunistic illnesses in US patients, 1994–2007: A cohort study. AIDS 24(10):1549–1559. CDC (Centers for Disease Control and Prevention). 2009. Cases of HIV Infection and AIDS in the United States and Dependent Areas, 00, Table . http://www.cdc.gov/hiv/topics/ surveillance/resources/reports/2007report/pdf/table1.pdf (accessed May 7, 2010). Dieterich, D. T., E. A. Lew, D. P. Kotler, M. A. Poles, and J. M. Orenstein. 1994. Treatment with albendazole for intestinal disease due to Enterocytozoon bieneusi in patients with AIDS. Journal of Infectious Diseases 169(1):178–183. Doumbo, O., J. F. Rossignol, E. Pichard, H. A. Traore, M. Dembele, M. Diakite, F. Traore, and D. A. Diallo. 1997. Nitazoxanide in the treatment of cryptosporidial diarrhea and other intestinal parasitic infections associated with acquired immunodeficiency syndrome in tropical Africa. American Journal of Tropical Medicine & Hygiene 56(6):637–639. Eron, Jr., J., P. Yeni, J. Gathe Jr., V. Estrada, E. DeJesus, S. Staszewski, P. Lackey, C. Katlama, B. Young, L. Yau, D. Sutherland-Phillips, P. Wannamaker, C. Vavro, L. Patel, J. Yeo, and M. Shaefer. 2006. The KLEAN study of fosamprenavir-ritonavir versus lopinavir- ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV in- fection over 48 weeks: A randomised non-inferiority trial. Lancet 368(9534):476–482. Fanning, M., M. Monte, L. R. Sutherland, M. Broadhead, G. F. Murphy, and A. G. Harris. 1991. Pilot study of sandostatin (octreotide) therapy of refractory HIV-associated diar- rhea. Digestie Diseases & Sciences 36(4):476–480. Gan, I., G. May, J. Raboud, J. Tilley, and R. Enns. 2003. Pancreatitis in HIV infection: Predic- tors of severity. American Journal of Gastroenterology 98(6):1278–1283. Gathe, J., B. A. da Silva, D. E. Cohen, M. R. Loutfy, D. Podzamczer, R. Rubio, S. Gibbs, T. Marsh, C. Naylor, L. Fredrick, and B. Bernstein. 2009. A once-daily lopinavir/ritonavir- based regimen is noninferior to twice-daily dosing and results in similar safety and toler- ability in antiretroviral-naïve subjects through 48 weeks. Journal of Acquired Immune Deficiency Syndromes 50(5):474–481. Kahn, J., S. Lagakos, D. Richman, A. Cross, C. Pettinelli, S. Liou, M. Brown, P. Volberding, C. Crumpacker, G. Beall, H. Sacks, T. Merigan, M. Beltangady, L. Smaldone, R. Dolin, and the NIAID AIDS Clinical Trials Group. 1992. A controlled trial comparing contin- ued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group. New England Journal of Medicine 327(9):581–587.

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