Longitudinal Study of Ocular Complications of AIDS (LSOCA)

HIV Infections Clinical Trial

— LSOCA  

Official title:

Studies of Ocular Complications of AIDS (SOCA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000168
• Other study ID #: NEI-71
• Secondary ID: 5U10EY008057
• Status: Completed
• Phase: N/A
• First received: September 23, 1999
• Last updated: June 10, 2015
• Start date: August 1998
• Est. completion date: August 2013

Study information

• Verified date: June 2015
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To monitor trends over time, in the incidence of CMV retinitis and other ocular complications of AIDS

To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune status on the risk of developing CMV retinitis and other ocular complications of AIDS

To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a population at high risk for CMV retinitis and other ocular complications of AIDS

To evaluate the effects of treatments for CMV retinitis and other ocular complications on visual function, quality of life, and survival.

Description:

Ocular abnormalities in patients with AIDS were first reported in 1982. The most common finding is a non-infectious "HIV retinopathy", characterized by cotton wool spots, intraretinal hemorrhages, and/or microaneurysms. These changes occur in approximately 50 percent of patients with AIDS. HIV retinopathy alone is not typically associated with clinical loss of vision, but functional deficits in patients with AIDS without other ocular complications may be due to this phenomenon.

CMV retinitis has had the most clinical importance of all the associated complications of AIDS. It is commonly seen in late stage AIDS, and even when treated has the potential to cause substantial loss of vision. CMV retinitis is also the most costly AIDS-related opportunistic infection; the mean monthly cost of treatment has been estimated at $7,825. The incidence of CMV retinitis has varied with changes in the therapeutic and prophylactic strategies for AIDS and its complications. It has been on the decline in recent years related to the increased use of highly active anti-retroviral therapy (HAART).

Other ocular complications of AIDS such as ocular toxoplasmosis, herpes zoster retinitis, and pneumocystis choroidopathy occur less frequently than CMV retinitis and HIV retinopathy. Their frequency has also changed over the course of the AIDS epidemic.

Because the epidemiology of AIDS is rapidly evolving, with HIV becoming more like a chronic disease, new information is needed on the incidence and course of ocular complications. We have little information about the effect of HAART therapy over time on changes in immune status and the risk of ocular complications of AIDS. More information is also needed to determine who is at risk for developing ocular complications of AIDS, and how treatment is affecting their visual function, quality of life, and survival.

The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is prospective observational study of patients with AIDS. Patients with a prior diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention (CDC) criteria with or without ocular complications will be enrolled over a 4 year period. Approximately 2,000 patients will be enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. Followup visits for patients without ocular complications will be scheduled every 6 months. Followup visits for patients with ocular complications at baseline or diagnosed during followup will be every 3 months. Followup data will include eye examinations, fundus photographs, visual function testing, medical history, hematology and serum chemistry, and collection of plasma and blood cells for banking. Analysis of banked specimens will include HIV RNA levels and CMV DNA levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2392
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion criteria:

• A diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention (CDC) definition (with or without clinical symptoms of CMV retinitis or other ocular complications of AIDS)

• Age 13 years or older

• Signed consent statement

• Patients with newly diagnosed (within 45 days of enrollment) Ocular Opportunistic Infections (OOIs)

• Patients without a newly diagnosed Ocular Opportunistic Infection (OOI) diagnosed with AIDS after 1 Jan 2001

Exclusion criteria:

• none.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cytomegalovirus Retinitis
• HIV Infections
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
United States	Emory Eye Clinic	Atlanta	Georgia
United States	The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	Cullen Eye Institute	Houston	Texas
United States	Division of Infectious Diseases, University of Indiana, Indianapolis	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	Shiley Eye Center, 0946	La Jolla	California
United States	Jules Stein Eye Institute	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	LSU Eye Center	New Orleans	Louisiana
United States	Department of Ophthalmology	New York	New York
United States	Department of Ophthalmology	New York	New York
United States	UMDNJ-New Jersey Medical School	Newark	New Jersey
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Francis I. Proctor Foundation	San Francisco	California
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (51)

Branch AD, Drye LT, Van Natta ML, Sezgin E, Fishman SL, Dieterich DT, Meinert CL, Jabs DA. Evaluation of hepatitis C virus as a risk factor for HIV-associated neuroretinal disorder. Clin Infect Dis. 2013 Dec;57(11):1618-25. doi: 10.1093/cid/cit550. Epub 2013 Sep 30. — View Citation

Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Mortality in hepatitis C virus-infected patients with a diagnosis of AIDS in the era of combination antiretroviral therapy. Clin Infect Dis. 2012 Jul;55(1):137-44. doi: 10.1093/cid/cis404. Epub 2012 Apr 24. — View Citation

Brown DM, Thorne JE, Foster GL, Duncan JL, Brune LM, Muñana A, Meinert CL, Jabs DA. Factors affecting attrition in a longitudinal study of patients with AIDS. AIDS Care. 2006 Oct;18(7):821-9. — View Citation

Freeman WR, Van Natta ML, Jabs D, Sample PA, Sadun AA, Thorne J, Shah KH, Holland GN; SOCA Research Group. Vision function in HIV-infected individuals without retinitis: report of the Studies of Ocular Complications of AIDS Research Group. Am J Ophthalmol. 2008 Mar;145(3):453-462. doi: 10.1016/j.ajo.2007.10.013. Epub 2008 Jan 11. — View Citation

Gangaputra S, Drye L, Vaidya V, Thorne JE, Jabs DA, Lyon AT; Studies of the Ocular Complications of AIDS (SOCA) Research Group. Non-cytomegalovirus ocular opportunistic infections in patients with acquired immunodeficiency syndrome. Am J Ophthalmol. 2013 Feb;155(2):206-212.e5. doi: 10.1016/j.ajo.2012.07.019. Epub 2012 Oct 12. — View Citation

Gangaputra S, Kalyani PS, Fawzi AA, Van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with disease-associated factors and mortality. Am J Ophthalmol. 2012 Mar;153(3):434-444.e1. doi: 10.1016/j.ajo.2011.08.028. Epub 2011 Oct 22. — View Citation

Gangaputra S, Pak JW, Peng Q, Hubbard LD, Thayer D, Krason Z, Joyce J, Danis RP; Studies of the Ocular Complications of AIDS Research Group. Transition from film to digital fundus photography in the Longitudinal Studies of the Ocular Complications of AIDS. Retina. 2012 Mar;32(3):600-5. doi: 10.1097/IAE.0b013e318221592f. — View Citation

Hendrickson SL, Jabs DA, Van Natta M, Lewis RA, Wallace DC, O'Brien SJ. Mitochondrial haplogroups are associated with risk of neuroretinal disorder in HIV-positive patients. J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):451-5. doi: 10.1097/QAI.0b013e3181cb8319. — View Citation

Holbrook JT, Colvin R, van Natta ML, Thorne JE, Bardsley M, Jabs DA; Studies of Ocular Complications of AIDS (SOCA) Research Group. Evaluation of the United States public health service guidelines for discontinuation of anticytomegalovirus therapy after immune recovery in patients with cytomegalovirus retinitis. Am J Ophthalmol. 2011 Oct;152(4):628-637.e1. doi: 10.1016/j.ajo.2011.04.007. Epub 2011 Jul 13. — View Citation

Holland GN, Kappel PJ, Van Natta ML, Palella FJ, Lyon AT, Shah KH, Pavan PR, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Association between abnormal contrast sensitivity and mortality among people with acquired immunodeficiency syndrome. Am J Ophthalmol. 2010 May;149(5):807-16. doi: 10.1016/j.ajo.2009.12.019. — View Citation

Hunt PW, Sinclair E, Rodriguez B, Shive C, Clagett B, Funderburg N, Robinson J, Huang Y, Epling L, Martin JN, Deeks SG, Meinert CL, Van Natta ML, Jabs DA, Lederman MM. Gut epithelial barrier dysfunction and innate immune activation predict mortality in treated HIV infection. J Infect Dis. 2014 Oct 15;210(8):1228-38. doi: 10.1093/infdis/jiu238. Epub 2014 Apr 21. — View Citation

Jabs DA, Ahuja A, Van Natta M, Dunn JP, Yeh S; Studies of the Ocular Complications of AIDS Research Group. Comparison of treatment regimens for cytomegalovirus retinitis in patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2013 Jun;120(6):1262-70. doi: 10.1016/j.ophtha.2012.11.023. Epub 2013 Feb 16. — View Citation

Jabs DA, Ahuja A, Van Natta M, Lyon A, Srivastava S, Gangaputra S; Studies of the Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: five-year outcomes. Ophthalmology. 2010 Nov;117(11):2152-61.e1-2. doi: 10.1016/j.ophtha.2010.03.031. Epub 2010 Jul 29. — View Citation

Jabs DA, Ahuja A, Van Natta ML, Lyon AT, Yeh S, Danis R; Studies of the Ocular Complications of AIDS Research Group. Long-term Outcomes of Cytomegalovirus Retinitis in the Era of Modern Antiretroviral Therapy: Results from a United States Cohort. Ophthalmology. 2015 Jul;122(7):1452-63. doi: 10.1016/j.ophtha.2015.02.033. Epub 2015 Apr 17. — View Citation

Jabs DA, Drye L, Van Natta ML, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Incidence and long-term outcomes of the human immunodeficiency virus neuroretinal disorder in patients with AIDS. Ophthalmology. 2015 Apr;122(4):760-8. doi: 10.1016/j.ophtha.2014.11.009. Epub 2015 Jan 16. — View Citation

Jabs DA, Holbrook JT, Van Natta ML, Clark R, Jacobson MA, Kempen JH, Murphy RL; Studies of Ocular Complications of AIDS Research Group. Risk factors for mortality in patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2005 May;112(5):771-9. — View Citation

Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; Studies of the Ocular Complications of AIDS Research Group. Longitudinal study of the ocular complications of AIDS: 1. Ocular diagnoses at enrollment. Ophthalmology. 2007 Apr;114(4):780-6. Epub 2007 Jan 25. — View Citation

Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; Studies of the Ocular Complications of AIDS Research Group. Longitudinal study of the ocular complications of AIDS: 2. Ocular examination results at enrollment. Ophthalmology. 2007 Apr;114(4):787-93. Epub 2007 Jan 8. — View Citation

Jabs DA, Van Natta ML, Kempen JH, Reed Pavan P, Lim JI, Murphy RL, Hubbard LD. Characteristics of patients with cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2002 Jan;133(1):48-61. — View Citation

Jabs DA, Van Natta ML, Sezgin E, Pak JW, Danis R; Studies of the Ocular Complications of AIDS Research Group. Prevalence of intermediate-stage age-related macular degeneration in patients with acquired immunodeficiency syndrome. Am J Ophthalmol. 2015 Jun;159(6):1115-1122.e1. doi: 10.1016/j.ajo.2015.01.037. Epub 2015 Mar 11. — View Citation

Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; Studies of Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 1. Retinitis progression. Ophthalmology. 2004 Dec;111(12):2224-31. — View Citation

Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; Studies of Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 2. Second eye involvement and retinal detachment. Ophthalmology. 2004 Dec;111(12):2232-9. — View Citation

Jabs DA. AIDS and ophthalmology, 2008. Arch Ophthalmol. 2008 Aug;126(8):1143-6. doi: 10.1001/archopht.126.8.1143. — View Citation

Jacobson MA, Maecker HT, Orr PL, D'Amico R, Van Natta M, Li XD, Pollard RB, Bredt BM; Adult AIDS Clinical Trials Group and the Studies of Ocular Complications of AIDS Research Group. Results of a cytomegalovirus (CMV)-specific CD8+/interferon- gamma+ cytokine flow cytometry assay correlate with clinical evidence of protective immunity in patients with AIDS with CMV retinitis. J Infect Dis. 2004 Apr 15;189(8):1362-73. Epub 2004 Mar 31. — View Citation

Jacobson MA, Tan QX, Girling V, Poon C, Van Natta M, Jabs DA, Inokuma M, Maecker HT, Bredt B, Sinclair E; Studies of Ocular Complications of AIDS Research Group. Poor predictive value of cytomegalovirus (CMV)-specific T cell assays for the development of CMV retinitis in patients with AIDS. Clin Infect Dis. 2008 Feb 1;46(3):458-66. doi: 10.1086/525853. — View Citation

Kalyani PS, Fawzi AA, Gangaputra S, van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with visual function. Am J Ophthalmol. 2012 Mar;153(3):428-433.e1. doi: 10.1016/j.ajo.2011.08.027. Epub 2011 Oct 22. — View Citation

Kalyani PS, Holland GN, Fawzi AA, Arantes TE, Yu F, Sadun AA; Studies of the Ocular Complications of AIDS Research Group. Association between retinal nerve fiber layer thickness and abnormalities of vision in people with human immunodeficiency virus infection. Am J Ophthalmol. 2012 Apr;153(4):734-42, 742.e1. doi: 10.1016/j.ajo.2011.09.019. Epub 2012 Jan 15. — View Citation

Kempen JH, Martin BK, Wu AW, Barron B, Thorne JE, Jabs DA; Studies of Ocular Complications of AIDS Researh Group. The effect of cytomegalovirus retinitis on the quality of life of patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2003 May;110(5):987-95. — View Citation

Kempen JH, Min YI, Freeman WR, Holland GN, Friedberg DN, Dieterich DT, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Risk of immune recovery uveitis in patients with AIDS and cytomegalovirus retinitis. Ophthalmology. 2006 Apr;113(4):684-94. — View Citation

Kempen JH, Sugar EA, Lyon AT, Lewis RA, Jabs DA, Heinemann MH, Dunn JP; Studies of Ocular Complications of AIDS Research Group. Risk of cataract in persons with cytomegalovirus retinitis and the acquired immune deficiency syndrome. Ophthalmology. 2012 Nov;119(11):2343-50. doi: 10.1016/j.ophtha.2012.05.044. Epub 2012 Jul 30. — View Citation

Kempen JH, Sugar EA, Varma R, Dunn JP, Heinemann MH, Jabs DA, Lyon AT, Lewis RA; Studies of Ocular Complications of AIDS Research Group. Risk of cataract among subjects with acquired immune deficiency syndrome free of ocular opportunistic infections. Ophthalmology. 2014 Dec;121(12):2317-24. doi: 10.1016/j.ophtha.2014.06.014. Epub 2014 Aug 8. — View Citation

Kozak I, Ahuja A, Gangaputra S, Van Natta ML, Thorne JE, Freeman WR. Optic nerve head morphology and visual field function in patients with AIDS and without infectious retinitis. Ocul Immunol Inflamm. 2012 Oct;20(5):342-8. doi: 10.3109/09273948.2012.694552. Epub 2012 Jun 14. — View Citation

Kozak I, Vaidya V, Van Natta ML, Pak JW, May KP, Thorne JE; Studies of the Ocular Complications of AIDS Research Group. The prevalence and incidence of epiretinal membranes in eyes with inactive extramacular CMV retinitis. Invest Ophthalmol Vis Sci. 2014 Jun 12;55(7):4304-12. doi: 10.1167/iovs.14-14479. — View Citation

Krauskopf K, Van Natta ML, Danis RP, Gangaputra S, Ackatz L, Addessi A, Federman AD, Branch AD, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Correlates of hypertension in patients with AIDS in the era of highly active antiretroviral therapy. J Int Assoc Provid AIDS Care. 2013 Sep-Oct;12(5):325-33. — View Citation

Lee SA, Sinclair E, Jain V, Huang Y, Epling L, Van Natta M, Meinert CL, Martin JN, McCune JM, Deeks SG, Lederman MM, Hecht FM, Hunt PW. Low proportions of CD28- CD8+ T cells expressing CD57 can be reversed by early ART initiation and predict mortality in treated HIV infection. J Infect Dis. 2014 Aug 1;210(3):374-82. doi: 10.1093/infdis/jiu109. Epub 2014 Feb 28. — View Citation

Limou S, Delaneau O, van Manen D, An P, Sezgin E, Le Clerc S, Coulonges C, Troyer JL, Veldink JH, van den Berg LH, Spadoni JL, Taing L, Labib T, Montes M, Delfraissy JF, Schachter F, O'Brien SJ, Buchbinder S, van Natta ML, Jabs DA, Froguel P, Schuitemaker H, Winkler CA, Zagury JF. Multicohort genomewide association study reveals a new signal of protection against HIV-1 acquisition. J Infect Dis. 2012 Apr 1;205(7):1155-62. doi: 10.1093/infdis/jis028. Epub 2012 Feb 23. — View Citation

Puhan MA, Ahuja A, Van Natta ML, Ackatz LE, Meinert C; Studies of Ocular Complications of AIDS Research Group. Interviewer versus self-administered health-related quality of life questionnaires - does it matter? Health Qual Life Outcomes. 2011 May 10;9:30. doi: 10.1186/1477-7525-9-30. — View Citation

Puhan MA, Van Natta ML, Palella FJ, Addessi A, Meinert C; Ocular Complications of AIDS Research Group. Excess mortality in patients with AIDS in the era of highly active antiretroviral therapy: temporal changes and risk factors. Clin Infect Dis. 2010 Oct 15;51(8):947-56. doi: 10.1086/656415. — View Citation

Semba RD, Martin BK, Kempen JH, Thorne JE, Wu AW; Ocular Complications of AIDS Research Group. The impact of anemia on energy and physical functioning in individuals with AIDS. Arch Intern Med. 2005 Oct 24;165(19):2229-36. — View Citation

Serrano-Villar S, Sainz T, Lee SA, Hunt PW, Sinclair E, Shacklett BL, Ferre AL, Hayes TL, Somsouk M, Hsue PY, Van Natta ML, Meinert CL, Lederman MM, Hatano H, Jain V, Huang Y, Hecht FM, Martin JN, McCune JM, Moreno S, Deeks SG. HIV-infected individuals with low CD4/CD8 ratio despite effective antiretroviral therapy exhibit altered T cell subsets, heightened CD8+ T cell activation, and increased risk of non-AIDS morbidity and mortality. PLoS Pathog. 2014 May 15;10(5):e1004078. doi: 10.1371/journal.ppat.1004078. eCollection 2014 May. — View Citation

Sezgin E, Hendrickson SL, Jabs DA, Van Natta ML, Lewis RA, Troyer JL, O'Brien SJ; SOCA Research Group. Effect of host genetics on incidence of HIV neuroretinal disorder in patients with AIDS. J Acquir Immune Defic Syndr. 2010 Aug;54(4):343-51. doi: 10.1097/QAI.0b013e3181deaf4d. — View Citation

Sezgin E, Jabs DA, Hendrickson SL, Van Natta M, Zdanov A, Lewis RA, Smith MW, Troyer JL, O'Brien SJ; SOCA Research Group. Effect of host genetics on the development of cytomegalovirus retinitis in patients with AIDS. J Infect Dis. 2010 Aug 15;202(4):606-13. doi: 10.1086/654814. — View Citation

Sezgin E, van Natta ML, Ahuja A, Lyon A, Srivastava S, Troyer JL, O'Brien SJ, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Association of host genetic risk factors with the course of cytomegalovirus retinitis in patients infected with human immunodeficiency virus. Am J Ophthalmol. 2011 Jun;151(6):999-1006.e4. doi: 10.1016/j.ajo.2010.11.029. Epub 2011 Mar 10. — View Citation

Shah KH, Holland GN, Yu F, Van Natta M, Nusinowitz S; Studies of Ocular Complications of AIDS (SOCA) Research Group. Contrast sensitivity and color vision in HIV-infected individuals without infectious retinopathy. Am J Ophthalmol. 2006 Aug;142(2):284-92. — View Citation

Sinclair E, Tan QX, Sharp M, Girling V, Poon C, Natta MV, Jabs DA, Inokuma M, Maecker HT, Bredt B, Jacobson MA; Studies of Ocular Complications of AIDS Research Group. Protective immunity to cytomegalovirus (CMV) retinitis in AIDS is associated with CMV-specific T cells that express interferon- gamma and interleukin-2 and have a CD8+ cell early maturational phenotype. J Infect Dis. 2006 Dec 1;194(11):1537-46. Epub 2006 Oct 26. — View Citation

Sugar EA, Jabs DA, Ahuja A, Thorne JE, Danis RP, Meinert CL; Studies of the Ocular Complications of AIDS Research Group. Incidence of cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2012 Jun;153(6):1016-24.e5. doi: 10.1016/j.ajo.2011.11.014. Epub 2012 Feb 4. — View Citation

Thorne JE, Holbrook JT, Jabs DA, Kempen JH, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Effect of cytomegalovirus retinitis on the risk of visual acuity loss among patients with AIDS. Ophthalmology. 2007 Mar;114(3):591-8. Epub 2006 Nov 22. — View Citation

Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Causes of visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006 Aug;113(8):1441-5. Epub 2006 Jun 15. — View Citation

Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006 Aug;113(8):1432-40. Epub 2006 Jun 12. — View Citation

Thorne JE, Van Natta ML, Jabs DA, Duncan JL, Srivastava SK; Studies of Ocular Complications of AIDS Research Group. Visual field loss in patients with cytomegalovirus retinitis. Ophthalmology. 2011 May;118(5):895-901. doi: 10.1016/j.ophtha.2010.09.017. Epub 2010 Dec 13. — View Citation

Weinberg DV, Holbrook JT, Hubbard LD, Davis MD, Jabs DA, Holland GN; Studies of Ocular Complications of AIDS Research Group. Clinician versus reading center assessment of cytomegalovirus retinitis lesion size. Ophthalmology. 2005 Apr;112(4):559-66. — View Citation

* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of CMV retinitis, other ocular complications, mortality.		Until one year after the enrollment of the last patient.	Yes
Secondary	incidence of sequelae of AIDS-related eye disease (e.g., retinal detachments), incidence of complications of therapy, and long-term outcomes of ocular complications (e.g., visual function, quality of life).		Until one year after the enrollment of the last patient.	Yes