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Publications

LSOCA Credit Roster (Nov 2012)

(Data are available upon request following review and approval by SOCA)


Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

1. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Studies of Ocular Complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. Controlled Clin Trials. 1992;13:22-39. PMID: 1315661

2. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. New Eng J Med. 1992;326:213-220. PMID: 1345799

3. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Foscarnet-Ganciclovir CMV Retinitis Trial: 4. Visual outcomes. Ophthalmology. 1994;101:1250-1261. PMID: 8035989

4. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Arch Int Med 1995;155:65-74. PMID: 7802522

5. Studies of Ocular Complications of AIDS Research Group; in collaboration with AIDS Clinical Trials Group. Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients with AIDS and cytomegalovirus retinitis. J Infect Dis. 1995;172:613-621. PMID: 7658051

6. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Assessment of cytomegalovirus retinitis: clinical evaluation vs centralized grading of fundus photographs. Arch Ophthalmol. 1996;114:791-805. PMID: 8660161

7. Wu AW, Coleson LC, Holbrook JT, Jabs DA; for the Studies of Ocular Complication of AIDS Research Group. Measuring visual function and quality of life in patients with cytomegalovirus retinitis: Development of a questionnaire. Arch Ophthalmol. 1996;114:841-847. PMID: 8660168

8. Studies of the Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Clinical vs. photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Arch Ophthalmol. 1996;114:848-855. PMID: 8660169

9. Studies of Ocular Complications of AIDS; in collaboration with the AIDS Clinical Trials Group. Cytomegalovirus (CMV) culture results, drug resistance, and clinical outcome in patients with AIDS and CMV retinitis treated with foscarnet or ganciclovir. J Infect Dis. 1997;176:50-58. PMID: 9207349

10. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Rhegmatogenous retinal detachment in patients with cytomegalovirus retinitis: The Foscarent-Ganciclovir Cytomegalovirus Retinitis Trial. Am J Ophthalmol. 1997;124:61-70. PMID: 9222234

11. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 5. Clinical features of cytomegalovirus retinitis at diagnosis. Am J Ophthalmol. 1997;124:141-157. PMID: 9262538

12. Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Quality of Life Res. 1997;6: 481-493. PMID: 9330549

13. Holbrook JT, Davis MD, Hubbard LD, Martin BK, Holland GN, Jabs DA, Gilpin AK, Meinert CL and Reshef DS; for the Studies of Ocular Complications of AIDS Research Group. Risk factors for advancement of cytomegalovirus retinitis in patients with AIDS. Arch Ophthalmol. 2000;118:1196-1204. PMID: 10980764

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CMV Retinitis Retreatment Trial (CRRT)

1. Studies of the Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Combination foscarnet and ganciclovir therapy vs. monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS: The Cytomegalovirus Retreatment Trial. Arch Ophthalmol. 1996;114: 23-33. PMID: 8540847

2. Martin BK, Gilpin AMK, Jabs DA, and Wu AW; for the Studies of Ocular Complications of AIDS Research Group. Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol. 2001;54:376-386.  PMID: 11305288

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HPMPC Peripheral CMV Retinitis Trial (HPCRT)

1. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: The HPMPC Peripheral Cytomegalovirus Retinitis Trial. A randomized, controlled trial. Ann Intern Med. 1997;126:264-274. PMID: 9036798

2. Jabs DA, Meinert CL, Lalezari JP. Letter to the Editor (response) regarding cidofovir for cytomegalovirus retinitis (HPCRT). Ann Int Med. 1997;127:490-491.

3. The Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. Long-term follow-up of patients with AIDS treated with parenteral cidofovir for cytomegalovirus retinitis: The HPMPC Peripheral Cytomegalovirus Retinitis Trial. AIDS. 2000;14:1571-1581. PMID: 10983644

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Monoclonal Antibody CMV Retinitis Trial (MACRT)

1. Studies of Ocular Complications of AIDS Research Group; in collaboration with the AIDS Clinical Trials Group. MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Monoclonal Antibody Cytomegalovirus Retinitis Trial. Arch Ophthalmol. 1997;115:1528-1536. PMID: 9400786

2. Jabs DA, Kaplan Gilpin AM, Min YI, Erice A, Kempen JH and Quinn TC; for the Studies of Ocular Complications of AIDS Research Group. HIV and CMV viral load and clinical outcomes in patients with AIDS and cytomegalovirus retinitis: The Monoclonal Antibody Cytomegalovirus Retinitis Trial. AIDS. 2002;16: 877-887.
PMID: 12232843

3. Davidson M, Min Y, Holbrook JT, Quinn T, Murphy R, Jabs DA, Jacobson M, and Meinert CL; for the Studies of Ocular Complications of AIDS Research Group. The Influence of filgrastim (granulocyte colony-stimulating factor on human immunodeficiency virus type 1 RNA in patients with cytopmegalovirus retinitis. J Inf Dis. 2002;186:1013-8. PMID: 12232843

4. Gilpin AM, Holbrook JT, Jabs DA, Meinert CL; for the Studies of Ocular Complications of AIDS Research Group. Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial. Controlled Clinical Trials. 2003;24(1):92-98.
PMID: 12559647

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Ganciclovir Cidofovir CMV Retinitis Trial (GCCRT)

1. The Studies of Ocular Complications of AIDS Research Group (SOCA); in collaboration with the AIDS Clinical Trials Group. The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir CMV Retinitis Trial. Am J Ophthalmol. 2001;131:457-467. PMID: 11292409

2. Dunn JP, Van Natta ML, Foster G, Kuppermann B, Martin DF, Zong A, and Jabs DA; for the Studies of Ocular Complications of AIDS Research Group.  Complications of Ganciclovir implant surgery in patients with CMV retinitis. Retina 24 (1): 41-50, 2004. PMID: 15076943

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Longitudinal Study of Ocular Complications of AIDS (LSOCA)

1. Jabs DA, Van Natta ML, Kempen JH, Pavan PR, Lim J, Murphy R, Hubbard L; for the Studies of Ocular Complications of AIDS Research Group. Characteristics of patients with CMV retinitis in the era of highly active anti-retroviral therapy (HAART). Am J Ophthalmol. 2002;133: 48-61. PMID: 11755839

2. Kempen JH, Martin BK, Wu A, Barron B, Thorne JE, Jabs DA; for the Studies of Ocular Complications of AIDS Research Group. The effect of cytomegalovirus retinitis on the quality of life of patients with acquired immune deficiency syndrome in the era of highly active anti-retroviral therapy. Ophthalmology. 2003;110 (5).
PMID: 12750102

3. Marshall BC, Jacobson MA, Adler SP; in collaboration with the Studies of Ocular Complications of AIDS Research Group. Avidity of Antibodies to Cytomegalovirus in HIV Seropositive Patients with and without CMV Retinitis. Viral Immunol. 2004;17(1):101-8. PMID: 15018666

4. Jacobson MA, Maecker HT, Orr PL, D'Amico R, Van Natta M, Li XD, Pollard RB, Bredt BM; for the Adults AIDS Clinical Trials Group and the Studies of Ocular Complications of AIDS Research Group.  Results of a CMV-Specific CD8+/IFNγ+Cytokine flow cytometry assay correlate with clinical evidence of protective immunity in AIDS patients with CMV retinitis. J Infect Dis. 2004;189: 1362-1373. PMID: 15073672

5. Jabs DA, Van Natta ML, Thorne JE, Weinberg DV Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; for the 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;111: 2224-2231. PMID: 15582078

6. Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; for the Studies of Ocular Complications of AIDS Research Group.  Course of cytomegalovirus retinitis in the era of highly active antiretorviral therapy: 2. Second eye involvement and retinal detachment. Ophthalmology. 2004;111: 2232-2239. PMID: 15582079
 
7. Weinberg DV, Holbrook JT, Hubbard LD, Davis MD, Jabs DA, Holland GN; for the Studies of Ocular Complications of AIDS Research Group. Clinician versus Reading Center Assessment of cytomegalovirus retinitis lesion size.  Ophthalmology. 2005;112: 559-566. PMID: 15808244
 
8. Jabs DA, Holbrook JT, Van Natta ML, Clark R, Jacobson MA, Kempen JH, Murphy RL; for the Studies of Ocular Complications of AIDS Research Group. Risk Factors for Mortality in Patients with AIDS in the era of HAART.  Ophthalmology. 2005;112:771-779. PMID: 15878056

9. 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;24,165 (19):2229-2236. PMID: 16246988

10. Kempen JH, Min Y-I, Freeman WR, Holland GN, Friedberg DN, Dieterich DT, Jabs DA; for the Studies of Ocular Complications of AIDS Research Group. Risk of immune recovery uveitis in patients with AIDS and cytomegalovirus retinitis. Ophthalmology. 2006;113(4):684-694. PMID: 16581429

11. Brown DM, Thorne JE, Foster GL, Duncan JL, Brune LM, Mũnana A, Meinert CL, Jabs DA; for the Studies of Ocular Complications of AIDS Research Group. Factors affecting attrition of patients with AIDS. AIDS Care. 2006;18(7):821-829.
PMID: 16971294

12. Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; for the Studies of Ocular Complications of AIDS (SOCA) Research Group. Incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus (CMV) retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006;113(8):1432-40. PMID: 16766032

13. Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; for the Studies of Ocular Complications of AIDS (SOCA) Research Group. Causes of visual acuity loss among patients with AIDS and CMV in the era of HAART. Ophthalmology. 2006;113:1441-1445. PMID: 16781775

14. Shah KH, Holland GH, Yu F, Van Natta M, Nusinowitz S; in collaboration with the 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;142: 284-292. PMID: 16876510

15. Sinclair E, Tan QX, Sharp M, Girling V, Poon C, Van Natta ML, 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 maturation phenotype. J Infect Dis. 12006;94(11):1537-46.
PMID: 17083038

16. Thorne JE, Holbrook JT, Jabs DA, Kempen JH, Nichols C, Meinert CL; for the Ocular Complications of AIDS Research Group. The effect of cytomegalovirus (CMV) retinitis on the risk of visual acuity loss among patients with AIDS. Ophthalmology. 2007;114:591-598. PMID: 17123624

17. Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; for the Studies of the Ocular Complications of AIDS Research Group. The Longitudinal Study of the Ocular Complications of AIDS: 1. Ocular diagnoses at enrollment. Ophthalmology. 2007;114:780-786. PMID: 17258320

18. Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; for the Studies of the Ocular Complications of AIDS Research Group. The Longitudinal Study of the Ocular Complications of AIDS: 2. Ocular examination results at enrollment. Ophthalmology. 2007;114:787-793. PMID: 17210182

19. Jacobson, MA, Tan QX, Girling V. Poon C, Van Natta ML, Jabs DA, Inokuma M, Maecker HT, Bredt B, and Sinclair E; for the 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;46:458-466. PMC: 2666016

20. Freeman WR, Van Natta ML, Jabs DA, Sample PA, Sadun AA, Thorne J, Shah KH, Holland GN; for the 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;45:453-462. PMC: 2959724

21. Jabs DA; for the Studies of Ocular Complications of AIDS Research Group. AIDS and ophthalmology. Arch Ophthalmol. 2008;126:1143-1146. PMID: 18695113

22. Holland GN, Kappel PJ, Van Natta ML, Palella FJ, Lyon AT, Shah KH, Pavan PR, Jabs DA; on behalf of the 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;149:807-816. PMID: 20399927

23. 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;53: 451-455. PMID: 20098332

24. Sezgin E, Jabs DA, Hendrickson SL, Van Natta M, Zdanov A, Lewis RA, Smith MW, Troyer JL, O’Brien SJ; for the SOCA Research Group. Effect of host genetics on CMV retinitis occurrence in patients with AIDS. J Infect Dis. 2010;202:606-613. PMC: 2932829

25. Sezgin E, Hendrickson SL, Jabs DA, Van Natta M, Lewis RA, Troyer JL, O’Brien SJ; for the SOCA Research Group. Effect of host genetics on incidence of HIV neuroretinal disorder in patients with AIDS. J Acquir Immune Defic Syndr. 2010;54:343-351. PMC: 2908809

26. Puhan M, Van Natta ML, Pallela FJ, Addessi A, Meinert CL. Excess mortality in patients with AIDS in the era of highly active antiretroviral therapy: Temporal changes and risk factors. Clin Inf Dis. 2010;51:947–956. PMC: 2943970

27. Jabs DA, Ahuja A, Van Natta M, Lyon A, Srivastava S, Gangaputra S; for the 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;117(11): 2152-61. PMC: 2963687

28. Thorne J, Van Natta ML, Jabs DA, Duncan J, Srivastava S; for the Studies of the Ocular Complications of AIDS Research Group. Visual field loss among patients with cytomegalovirus retinitis. Ophthalmology. 2011;118:895-901. PMC: 3087851

29. Sezgin E, Van Natta M, Ahuja A, Lyon A, Srivastava S, Troyer JL, O’Brien SJ, Jabs DA; for the SOCA Research Group. Association of Host Genetic Risk Factors with the Course of Cytomegalovirus Retinitis in Patients Infected with HIV. Am J Ophthalmol. 2011;151:999-1006. PMC: 3103625

30. Holbrook JT, Colvin R, Van Natta ML, Thorne JE, Bardsley M, Jabs DA; for the Studies of Ocular Complications of AIDS (SOCA) Research Group. Evaluation of the United States Public Health Service guidelines for discontinuation of anti-cytomegalovirus therapy after immune recovery in patients with CMV retinitis. Am J Opthalmol 2011;154(4):628-637. PMC: 3185165

31. Puhan M, Ahuja A, Van Natta ML, Ackatz LE, Meinert CL; for the Studies of Ocular Complications of AIDS Research Group. Interviewer versus self-administered health-related quality of life questionnaires - Does it matter? HQLO 2011;9:30. PMC: 3100232

32. Gangaputra S, Won Pak J, Peng Q, Hubbard LD, Thayer D, Krason Z, Joyce J, Danis RP; for the Studies of Ocular Complications of AIDS Research Group. Transition from film to digital fundus photography in the Longitudinal Studies of Ocular Complications of AIDS. Retina 2012;32:600-605. PMID: 21857393

33. Gangaputra S, Kalyani PS, Fawzi AA, Van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; on behalf of the Studies of Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with AIDS: Relationship with disease-associated factors and mortality. Am J Ophthalmol 2012;153:434-444. PMC: 3289046

34. Kalyani PS, Fawzi AA, Gangaputra S, Van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; on behalf of the Studies of Ocular Complications of AIDS Research Group.  Retinal vessel caliber among people with AIDS: Relationships with visual function. Am J Ophthalmol 2012;153:428-433. PMID: 22019221

35. Sugar EA, Jabs DA, Ahuja A, Thorne JE, Danis RP, Meinert CL; for the Studies of Ocular Complications of AIDS Research Group.  Incidence of cytomegalovirus retinitis in the era of highly active antiretrovial therapy. Am J Ophthalmol 2012;153:1016-1024. PMC: 3358595

36. Limou S, Delameau O, van Manen D, An P, Sezgin E, Le Clerc S, et al. Multicohort genomewide association study reveals a new signal of protection against HIV-1 acquistion. J Infect Dis 2012;205:1155-1162.  PMC: 3295605

37. Kalyani PS, Holland GN, Fawzi AA, Arantes TEF, Sadun AA; in collaboration with the Studies of Ocular Complication 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;153(4):734-742. PMID: 222454559

38. Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert LC, Jabs DA; for the Studies of Ocular Complications of AIDS Research Group.  Mortality in HCV-infected patients with a diagnosis of AIDS in the era of combination anti-retroviral therapy.  Clin Infect Dis 2012;55(1):137-144. PMC: 336965

39. Kempen JH, Sugar EA, Lyon AT, Lewis RA, Jabs DA, Heinemann MH, Dunn JP for the Studies of Ocular Complications of AIDS.  Risk of cataract in persons with cytomegalovirus retinitis and the acquired immune deficiency syndrome. Ophthalmology 2012; 119:2343-2350. PMID: 22853972

40. Althoff K, Buchacz K, Hall IH, Zhang J, Hanna DB, Rebeiro P, Gange SJ, Moore RD, Kitahata MM, Gebo KA, Martin J, Justice AC, Horberg MA, Hogg RS, Sterling TR, Cescon A, Klein MV, Thorne JE, Crane HM, Gugavero MJ, Napravnik S, Kirk GD, Jacobson LP, Brooks JT for the North American AIDS Cohort Collaboration on Resarch and Design.  US Trends in antiretroviral therapy use, HIV RNA plasma viral loads, and CD4 T-Lymphocyte cell counts among HIV-infected persons.  Ann Intern Med 2012; 157:325-335. PMID: 22944874

41. Gangaputra S, Drye L, Vaidya V, Thorne JE, Jabs DA, Lyon A for the Studies of the Ocular Complications of AIDS Research Group.  Non-cytomegalovirus ocular opportunistic infections in patients with AIDS.  Am J Ophthalmol 2013; 155(2):206-212. PMID: 23068916

42, Jabs DA, Ajuja A, Van Natta ML, Dunn JP, Yeh S for the Studies of 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 Feb 2013, in press.

43. Krauskopf K, Van Natta ML, Danis RP, Gangaputra S, Federman AD, Branch AD, Meinert CL, Jabs DA for the Studies of Ocular Complications of AIDS Research Group. Correlates of hypertension in patients with AIDS in the era of highly active antiretroviral therapy. JIAPAC, 15Apr2013, (accepted).

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Studies of Ocular Complications of AIDS (SOCA)

1. Holbrook JT, Meinert CL, Van Natta ML, Davis MD, Hubbard L, Jabs DA; for the Studies of Ocular Complications of AIDS Research Group. Photographic measures of cytomegalovirus retinitis as surrogates for visual outcomes in treated patients. Arch Ophthalmol. 2001;119:554-563. PMID: 11296021

2. Holbrook JT, Meinert CL, Jabs DA; for the Studies of Ocular Complications of AIDS Research Group. Patient notification and followup after suspension of treatment protocols: Experience from four clinical trials of treatments for AIDS-related CMV Retinitis. Controlled Clin Trials. 2002;22:62-68. PMID: 11165425

3. Davidson M, Min Y, Holbrook JT, Van Natta ML, Murphy R, Jabs DA, Welch W, and Meinert CL; for the Studies of Ocular Complications of AIDS Research Group. Use of filgrastim (G-CSF) as adjuvant therapy in patients with AIDS-related cytomegalovirus retinitis. AIDS. 2002;16: 757-765. PMID: 11964532

4. Holbrook JT, Jabs DA, Lewis RA, Weinberg D, Davis MD, Friedberg D; for the Studies of Ocular Complications of AIDS Research Group. Visual loss in patients with cytomegalovirus retinitis and AIDS before wide spread availability of highly active antiretroviral therapy. Arch Ophthalmol. 2003;121(1):99-107. PMID: 12523893
 

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Other Publications

These books are available at http://www.amazon.com

Clinical Trials Dictionary: Terminology and Usage Recommendations.  Meinert, CL. Baltimore, MD, 1996.

Clinical Trials: Design, Conduct, and Analysis. Meinert, CL. New York, 1986.

Clinical Trials: A Methodologic Perspective. Piantadosi, S. New York, 1997.

Clinical Trials: An Insider's Guide to Clinical Trials. Meinert, CL. Oxford University Press, 2011.
 

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Last updated Monday, May 13, 2013