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

NCT ID: NCT00431548

Last Updated: 2007-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Retina Ocular Physiology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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100% O2

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Hans-Georg Eichler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-180198

Identifier Type: -

Identifier Source: org_study_id

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