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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000705
First received: November 2, 1999
Last updated: August 4, 2014
Last verified: August 2014

November 2, 1999
August 4, 2014
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Complete list of historical versions of study NCT00000705 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia
A Phase I Trial to Evaluate Azidothymidine (AZT) in the Treatment of HIV Infections in Patients With Hemophilia

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hemophilia A
Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 1989
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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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000705
ACTG 017, 10993
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Richard C. Reichman
National Institute of Allergy and Infectious Diseases (NIAID)
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP