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
13:22-39, 1992.
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 326:213-220, 1992.*
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
101:1250-1261, 1994.
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
155:65-74, 1995.
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 172:613-621, 1995.
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
114:791-805, 1996.
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
114:841-847, 1996.
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
114:848-855, 1996.
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
176:50-58, 1997.
10. 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
124:141-157, 1997.
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 124:141-157,
1997.
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
6: 481-493, 1997.
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 118:1196-1204,
2000.
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 114:
23-33, 1996.*
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 54:376-386,
2001.
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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
126:264-274, 1997.*
2. Jabs DA, Meinert CL, Lalezari
JP: Letter to the Editor
(response) regarding cidofovir
for cytomegalovirus retinitis (HPCRT).
Ann Int Med 127:490-491,
1997.
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
14:1571-1581, 2000.
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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 115:1528-1536,
1997.*
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 16: 877-887, 2002.
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 186:1013-8,
2002.
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, 24(1):92-98,
2003.
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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 131:457-467,
2001.*
2. Dunn JP, Heinemann M-H, Jabs
DA, Kuppermann B, Martin D Van
Natta ML, and Zong A 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.
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 133: 48-61,
2002.*
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 110 (5), 2003.*
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. 17(1):101-8,
2004.
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. 189: 1362-1373,
2004.
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 111:
2224-2231. 2004.*
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 111:
2232-2239, 2004.*
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
112: 559-566, 2005.*
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
112: 771-779, 2005.*
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. 24, 165 (19)
:2229-2236, 2005.
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 113(4):
684-694, 2006.*
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, 18(7):
821-829, 2006.*
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,
113(8): 1432-40, 2006.*
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,
113:1441-1445, 2006.*
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, 142: 284-292,
2006.
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. 194(11):
1537-46, 2006.
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,
114:591-598, 2007.*
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
114: 780-786, 2007.
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 114: 787-793,
2007.
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 46:458-466,
2008.
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 45:453-462,
2008.
21. Jabs DA,
for the Studies of Ocular
Complications of AIDS Research
Group. AIDS and ophthalmology,
2008. Arch Ophthalmol
126:1143-1146, 2008.
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
119:554-563, 2001.
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 22:62-68, 2002.
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
16: 757-765, 2002.
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 121 (1): 99-107,
2003.
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Commissioned papers
1. Thorne JE: Longitudinal
analysis of visual field loss in
patients with CMV Retinitis.
(LSOCA, commissioned Aug 03/recommissioned
June 2006).
2. Holland GN: Chronic CMV
reactivation and its
relationship to the progression
of CMV retinitis in patients
with AIDS. (LSOCA,
commissioned Nov 03).
3. Holland GN in collaboration
with the Studies of Ocular
Complications of AIDS Research
Group: Factors related to
cytomegalovirus retinitis lesion
opacity. (SOCA Study Combination
commissioned Nov 02).
4. Holbrook JT: Evaluation of CMV retinitis treatment
guidelines on mortality and
visual function in the LSOCA
Cohort. (LSOCA, commissioned Jul
05).
5. Kempen JH: Risk of cataract
in patients with AIDS. (LSOCA,
commissioned Sep 05).
6. Holland GN: Longitudinal study
of contrast sensitivity among
individuals with AIDS but no
retinal infections.
(commissioned Dec 06).
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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.
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*Data are
available upon request following
review and approval by SOCA |