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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00431548
First received: February 5, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention
HIV Infections
Retina
Ocular Physiology
 Drug: 100% O2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change

Estimated Enrollment: 30
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431548

Locations
Austria
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431548     History of Changes
Other Study ID Numbers: OPHT-180198
Study First Received: February 5, 2007
Last Updated: February 5, 2007
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013