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

February 5, 2007 updated by: Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 6, 2007

Last Update Submitted That Met QC Criteria

February 5, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-180198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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