Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

There is a clear risk for development of AIDS in hemophilic patients. AZT administration has been shown to inhibit HIV replication in vitro. Patients taking AZT have experienced fewer opportunistic infections and improvements in measures of immunity. The most common laboratory abnormalities observed with AZT are hematologic. However, the clinical and laboratory toxicity of AZT remains poorly understood in hemophiliacs. Hepatitis and liver dysfunction are more common in this population compared to other groups at risk for HIV infection. Because AZT is largely metabolized in the liver, drug p...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive.
• • Have a bleeding disorder such as hemophilia A or B, a lack of factor VIII (a blood clotting factor), or severe von Willebrand's disease.
• • Will be available for follow-up for at least a year.
• • Are at least 12 years old (consent of parent or guardian required if under 18).
• • Are willing to use an effective method of birth control during the study.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have a life-threatening opportunistic (AIDS-related) infection or AIDS-related symptoms.
• • Have taken certain drugs within 30 days prior to study entry including chemotherapy and interferon.
• • Are taking acetaminophen or drugs containing acetaminophen.
• • Are pregnant or breast-feeding.

Trial Officials