HIV InfectionsNCT00431548
Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)
A study testing 100% O2 in people with HIV Infections and Retina, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- HIV Infections, Retina, Ocular Physiology
- What is being tested?
- 100% O2
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 19 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Group 1 (Patients with HIV)
- Aged between 19 and 70 years, male and female
- HIV positive patients without HIV-related retinopathy with a CD4+ cell count 500 cells/mm3 stage A2, A3, B2, B3, C2 and C3.
- Best corrected visual acuity >= 0.8
- Ametropy < 6 dpt
- Group 2 (Healthy control subjects)
Show all 11Show fewer
- Aged between 19 and 70 years
- Age and sex matched to the subjects in the HIV group (group matched)
- Matched with regard to the smoking habits in the HIV group
- Best corrected visual acuity >= 0.8
- Ametropy < 6 dpt
Who cannot join
- Evidence of any other eye disease
- Diabetes mellitus
- Systemic hypertension (defined as SBP > 150 mmHg or DBP > 90 mmHg)
- Abuse of illegal drugs
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Official title: Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).
Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several hypotheses including infectious damage of the retinal vasculature and altered retinal hemodynamics have been postulated. The latter would be compatible with the theory that the retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the retina is not possible and indirect methods have to be employed. The study objective was to investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with HIV.
- Conditions
- HIV Infections, Retina, Ocular Physiology
- Being tested
- 100% O2
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% O2Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
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.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Georg Eichler, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431548
- Sponsor's protocol ID
- OPHT-180198
- Status last verified
- Feb 2007
- First submitted
- 5 Feb 2007
- Last updated
- 6 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).
- ClinicalTrials.gov ID
- NCT00431548
- Acronym / sponsor ID
- OPHT-180198
- Conditions
- HIV Infections, Retina, Ocular Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- First posted
- 6 Feb 2007 (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.
Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several hypotheses including infectious damage of the retinal vasculature and altered retinal hemodynamics have been postulated. The latter would be compatible with the theory that the retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the retina is not possible and indirect methods have to be employed. The study objective was to investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Group 1 (Patients with HIV)
- Aged between 19 and 70 years, male and female
- HIV positive patients without HIV-related retinopathy with a CD4+ cell count 500 cells/mm3 stage A2, A3, B2, B3, C2 and C3.
- Best corrected visual acuity >= 0.8
- Ametropy < 6 dpt
Key exclusion criteria (4 listed)
- Evidence of any other eye disease
- Diabetes mellitus
- Systemic hypertension (defined as SBP > 150 mmHg or DBP > 90 mmHg)
- Abuse of illegal drugs
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 |
|---|---|---|
| 100% O2 | Drug | – |
Primary outcome
Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change
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 6 Feb 2007.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Hans-Georg Eichler, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% O2 in people with HIV Infections and Retina, run by Medical University of Vienna at 1 site in Austria.
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 11 inclusion and 4 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 6 Feb 2007. 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 Austria. 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?
Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change. It is what the study was designed to measure, not a finding.
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 6 Feb 2007.