HIV InfectionsNCT00871078
Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients
An observational study of HIV Infections and Acquired Immunodeficiency Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- Optical Coherence Tomography (OCT) and Frequency Doubling Technology (FDT) perimeter
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Sep 2009
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: HIV infected patients
Who may be able to join
- Clinical diagnosis of AIDS
- Best-corrected visual acuity 20/25 or better
- Refractive error of 0±5.0 diopters and astigmatism of 0±3.0 diopters
- Normal intraocular pressure (≤21mmHg)
Who cannot join
- Cataract or any visible media opacity
- HIV-related infectious retinopathy
- Risk factors for the development of glaucoma
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of São Paulo (UNIFESP/EPM)
São Paulo, São Paulo
About this study
Official title: Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients Using Optical Coherence Tomography and Frequency Doubling Technology Perimetry
The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (FDT).
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- Optical Coherence Tomography (OCT), Frequency Doubling Technology (FDT) perimeter
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Device
Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls
Frequency Doubling Technology (FDT) perimeterDevice
24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.
| Study group | Role | What they receive |
|---|---|---|
| A | HIV-positive patients with CD4 cell counts below 100 cells/mm³ at some point of time in their medical history lasting for at least 6 months Receives: Device: Optical Coherence Tomography (OCT); Device: Frequency Doubling Technology (FDT) perimeter | |
| B | HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records Receives: Device: Optical Coherence Tomography (OCT); Device: Frequency Doubling Technology (FDT) perimeter | |
| C | HIV-negative patients (control group) Receives: Device: Optical Coherence Tomography (OCT); Device: Frequency Doubling Technology (FDT) perimeter |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Tiago Arantes, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871078
- Sponsor's protocol ID
- BRA-713/06
- Status last verified
- Sep 2009
- First submitted
- 27 Mar 2009
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients Using Optical Coherence Tomography and Frequency Doubling Technology Perimetry
- ClinicalTrials.gov ID
- NCT00871078
- Acronym / sponsor ID
- BRA-713/06
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Mar 2009 (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.
The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (FDT).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Optical Coherence Tomography (OCT), Device: Frequency Doubling Technology (FDT) perimeterHIV-positive patients with CD4 cell counts below 100 cells/mm³ at some point of time in their medical history lasting for at least 6 months |
| B | – | Device: Optical Coherence Tomography (OCT), Device: Frequency Doubling Technology (FDT) perimeterHIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records |
| C | – | Device: Optical Coherence Tomography (OCT), Device: Frequency Doubling Technology (FDT) perimeterHIV-negative patients (control group) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- HIV infected patients
Key inclusion criteria (4 listed)
- Clinical diagnosis of AIDS
- Best-corrected visual acuity 20/25 or better
- Refractive error of 0±5.0 diopters and astigmatism of 0±3.0 diopters
- Normal intraocular pressure (≤21mmHg)
Key exclusion criteria (3 listed)
- Cataract or any visible media opacity
- HIV-related infectious retinopathy
- Risk factors for the development of glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography (OCT)Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls | Device | A, B, C |
| Frequency Doubling Technology (FDT) perimeter24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls. | Device | A, B, C |
Primary outcome
Not reported in the source record.
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 29 Sep 2009.
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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.
Tiago Arantes, MD principal investigator
Federal University of São Paulo
1 site 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 Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 3 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 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
Where can I read the original study information?
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 29 Sep 2009.