Multiple-dose pharmacokinetics of oral zidovudine in hemophilia patients with human immunodeficiency virus infection.
G D Morse, A Portmore, J Olson...
https://pubmed.ncbi.nlm.nih.gov/2334151Completed
Phase 1
Age: 12Years +
All Genders
ID00000705
A Phase I Trial to Evaluate Azidothymidine (AZT) in the Treatment of HIV Infections in Patients With Hemophilia
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
24
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune system. HIV infects and inactivates certain blood cells that are part of the body's immune system. The damage to the body's immune system can result in unusual infections and/or unusual forms of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients. AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients.
CONDITIONS
Official Title
Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
2
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Pharmacokinetics of orally administered zidovudine among patients with hemophilia and asymptomatic human immunodeficiency virus (HIV) infection.
G D Morse, J Olson, A Portmore...
https://pubmed.ncbi.nlm.nih.gov/2729955