Back to resultsRetinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)
Primary Purpose
HIV Infections, Retina, Ocular Physiology
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
100% O2
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
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)
- 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
Exclusion Criteria:
- Evidence of any other eye disease
- Diabetes mellitus
- Systemic hypertension (defined as SBP > 150 mmHg or DBP > 90 mmHg)
- Abuse of illegal drugs
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Outcomes
Primary Outcome Measures
Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change
Secondary Outcome Measures
Full Information
NCT ID
NCT00431548
First Posted
February 5, 2007
Last Updated
February 5, 2007
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00431548
Brief Title
Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)
Official Title
Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Retina, Ocular Physiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
100% O2
Primary Outcome Measure Information:
Title
Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
Evidence of any other eye disease
Diabetes mellitus
Systemic hypertension (defined as SBP > 150 mmHg or DBP > 90 mmHg)
Abuse of illegal drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Georg Eichler, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)
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