Brief Title
Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia
Official Title
A Phase I Trial to Evaluate Azidothymidine (AZT) in the Treatment of HIV Infections in Patients With Hemophilia
Brief Summary
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.
Detailed Description
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 pharmacokinetics needs to be evaluated
in this patient population.
Both hemophiliacs and non-hemophiliacs take AZT for a period of 12 weeks. The first dose is
administered intravenously. AZT is then given orally every 4 hours while awake (5 doses per
day). Patients are evaluated by physical examinations and laboratory assessments. These
include HIV culture of blood and leukocyte counts, lymphocyte counts, and lymphocyte subsets
measured at study entry and every 4 weeks thereafter. Patients are hospitalized for
pharmacokinetic studies at study entry and at Weeks 6 and 12. Each of these studies involves
both intravenous and oral administration within 48 hours of one another. Blood is sampled at
0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after each administration and urine is collected
every 2 hours for 12 hours.
Study Phase
Phase 1
Study Type
Interventional
Condition
HIV Infections
Intervention
Zidovudine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Completion Date
March 1989
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.
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Richard C. Reichman, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00000705
Organization ID
ACTG 017
Secondary IDs
10993
Responsible Party
Sponsor
Study Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor
Richard C. Reichman, Study Chair,
Verification Date
August 2014