HIV InfectionsLSOCANCT00000168
Longitudinal Study of Ocular Complications of AIDS (LSOCA)
An observational study of HIV Infections and Acquired Immunodeficiency Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 19 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome, Cytomegalovirus Retinitis
- How many people
- 2,392 participants
- Where
- 19 sitesUnited States
- Study dates
- Aug 1998to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of AIDS according to the 1993 CDC diagnostic criteria for AIDS and diagnosed on or after 01 January 2001 will be eligible for enrollment.
Who may be able to join
- 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
Who cannot join
- none.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory Eye Clinic
Atlanta, Georgia, 30322
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-9217
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7040
Northwestern University
Chicago, Illinois, 60611
University of Texas Medical Branch
Galveston, Texas, 77555-0835
Cullen Eye Institute
Houston, Texas, 77030
Division of Infectious Diseases, University of Indiana, Indianapolis
Indianapolis, Indiana, 46202-2879
University of California, Irvine
Irvine, California, 92697-4375
Shiley Eye Center, 0946
La Jolla, California, 92093-0946
University of Southern California
Los Angeles, California, 90033
Jules Stein Eye Institute
Los Angeles, California, 90095-7003
Bascom Palmer Eye Institute
Miami, Florida, 33136
LSU Eye Center
New Orleans, Louisiana, 70112
Department of Ophthalmology
New York, New York, 10016
Department of Ophthalmology
New York, New York, 10021
UMDNJ-New Jersey Medical School
Newark, New Jersey, 07103-2499
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Francis I. Proctor Foundation
San Francisco, California, 94143
University of South Florida
Tampa, Florida, 33612-4799
About this study
Official title: Studies of Ocular Complications of AIDS (SOCA)
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.
Read the detailed 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.
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Cytomegalovirus Retinitis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CMV retinitis, other ocular complications, mortality.
Measured: Until one year after the enrollment of the last patient.
Secondary outcomes (1)
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).
Measured: Until one year after the enrollment of the last patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startAug 1998
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Curtis Meinert, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Doug A Jabs, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000168
- Sponsor's protocol ID
- NEI-71
- Other IDs
- 5U10EY008057
- Acronym
- LSOCA
- Status last verified
- Jun 2015
- First submitted
- 23 Sep 1999
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1016/s0002-9394(01)01322-8.
PubMed 11755839Kempen 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. doi: 10.1016/S0161-6420(03)00089-7.
PubMed 12750102Jacobson 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. doi: 10.1086/382964. Epub 2004 Mar 31.
PubMed 15073672Jabs 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. doi: 10.1016/j.ophtha.2004.05.031.
PubMed 15582078Jabs 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. doi: 10.1016/j.ophtha.2004.05.028.
PubMed 15582079Weinberg 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. doi: 10.1016/j.ophtha.2004.11.027.
PubMed 15808244Jabs 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. doi: 10.1016/j.ophtha.2004.10.049.
PubMed 15878056Semba 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. doi: 10.1001/archinte.165.19.2229.
PubMed 16246988Kempen 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. doi: 10.1016/j.ophtha.2005.10.067.
PubMed 16581429Brown DM, Thorne JE, Foster GL, Duncan JL, Brune LM, Munana A, Meinert CL, Jabs DA. Factors affecting attrition in a longitudinal study of patients with AIDS. AIDS Care. 2006 Oct;18(7):821-9. doi: 10.1080/09540120500466747.
PubMed 16971294Thorne 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. doi: 10.1016/j.ophtha.2006.03.021. Epub 2006 Jun 12.
PubMed 16766032Thorne 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. doi: 10.1016/j.ophtha.2006.03.022. Epub 2006 Jun 15.
PubMed 16781775Shah 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. doi: 10.1016/j.ajo.2006.03.046.
PubMed 16876510Sinclair 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. doi: 10.1086/508997. Epub 2006 Oct 26.
PubMed 17083038Thorne 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. doi: 10.1016/j.ophtha.2006.08.008. Epub 2006 Nov 22.
PubMed 17123624
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Ocular Complications of AIDS (SOCA)
- ClinicalTrials.gov ID
- NCT00000168
- Acronym / sponsor ID
- LSOCA / NEI-71
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,392 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Aug 1998
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of AIDS according to the 1993 CDC diagnostic criteria for AIDS and diagnosed on or after 01 January 2001 will be eligible for enrollment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of CMV retinitis, other ocular complications, mortality.
Time frame: Until one year after the enrollment of the last patient.
1 secondary outcome
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).
Time frame: Until one year after the enrollment of the last patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Background: PubMed 11755839Jabs 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. doi: 10.1016/s0002-9394(01)01322-8.
- Background: PubMed 12750102Kempen 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. doi: 10.1016/S0161-6420(03)00089-7.
- Background: PubMed 15073672Jacobson 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. doi: 10.1086/382964. Epub 2004 Mar 31.
- Background: PubMed 15582078Jabs 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. doi: 10.1016/j.ophtha.2004.05.031.
- Background: PubMed 15582079Jabs 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. doi: 10.1016/j.ophtha.2004.05.028.
- Background: PubMed 15808244Weinberg 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. doi: 10.1016/j.ophtha.2004.11.027.
- Background: PubMed 15878056Jabs 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. doi: 10.1016/j.ophtha.2004.10.049.
- Background: PubMed 16246988Semba 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. doi: 10.1001/archinte.165.19.2229.
- Background: PubMed 16581429Kempen 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. doi: 10.1016/j.ophtha.2005.10.067.
- Background: PubMed 16971294Brown DM, Thorne JE, Foster GL, Duncan JL, Brune LM, Munana A, Meinert CL, Jabs DA. Factors affecting attrition in a longitudinal study of patients with AIDS. AIDS Care. 2006 Oct;18(7):821-9. doi: 10.1080/09540120500466747.
- Background: PubMed 16766032Thorne 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. doi: 10.1016/j.ophtha.2006.03.021. Epub 2006 Jun 12.
- Background: PubMed 16781775Thorne 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. doi: 10.1016/j.ophtha.2006.03.022. Epub 2006 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug A Jabs, MD study chair
Icahn School of Medicine at Mount Sinai
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Acquired Immunodeficiency Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CMV retinitis, other ocular complications, mortality. (time frame: Until one year after the enrollment of the last patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000168, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.