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Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00431548
Collaborator
(none)
30
Enrollment
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 100% O2
 N/A

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).

Outcome Measures

Primary Outcome Measures

  1. Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change []

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Hans-Georg Eichler, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00431548
Other Study ID Numbers:
  • OPHT-180198
First Posted:
Feb 6, 2007
Last Update Posted:
Feb 6, 2007
Last Verified:
Feb 1, 2007
Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome

Study Results

No Results Posted as of Feb 6, 2007