To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for
health care workers at risk for HIV infection from exposure to HIV-contaminated blood or
blood components.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- A prior history of a malignancy other than cutaneous basal cell or cervical
carcinomas.
- Other significant, chronic underlying medical illness which, in the physician's
judgment, would impair study completion.
- Evidence of compromised bone marrow function (lab results) with a blood transfusion
within the last month.
- Liver dysfunction as indicated by lab results.
Patients are excluded if there is a prior diagnosis of HIV infection by one of the
following criteria:
- HIV antibody positive by ELISA and Western blot assays or by other certified test
method. (Patients who are ELISA positive but Western blot or other confirmatory tests
are negative may continue in study).
- HIV antigen positive.
- Clinical symptoms which lead to a diagnosis by a licensed physician of AIDS or AIDS
related complex or AIDS-related dementia. Also excluded are individuals who have
experienced similar HIV exposure as described in this protocol in the past month and
individuals who have previously been enrolled in this study. The purpose of these
exclusions is to eliminate possible seroconversion in an individual that could be
attributed to HIV exposure other than the single exposure experienced just prior to
entry into the study.
Prior Medication:
Excluded within 4 weeks of study entry:
- Any potentially myelosuppressive drug.
- Nephrotoxic agent.
- Other experimental therapy.
Exposure of a health care worker to HIV-contaminated blood or blood component within 5 days
prior to beginning therapy, defined as one of the following:
- Penetrating wound from needle recently removed from patient or sample container (e. g.,
blood bag, blood tube) or from sharp object visibly contaminated with HIV-positive
blood or blood component. In the case of needlesticks or cuts with sharp objects,
blood or blood component must not have been exposed to the air for more than 1 hour.
If actual infusion of blood occurs, the 1-hour time limit does not apply.
- Hypodermic needles should come in contact with the blood and blood component from an
HIV source but need not be visibly contaminated with blood to be considered a source
of contamination.
- Significant exposure to HIV-positive blood or blood component as the result of splash
on abraded skin.
- Significant exposure to HIV-positive blood or blood component as the result of splash
on mucous membranes.
- Participant must be able to give informed consent.
Active drug or alcohol abuse sufficient in the physician's opinion to prevent compliance
with the study regimen.
