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NCT00431548 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00431548
Other study ID # OPHT-180198
Secondary ID
Status Completed
Phase N/A
First received February 5, 2007
Last updated February 5, 2007

Study information
Verified date February 2007
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 19 Years to 70 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 100% O2

Locations
Country Name City State
Austria Department of Clinical Pharmacology, Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change
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