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

NCT00000705 | Completed Phase 1

• 2 other identifiers: ACTG 01710993
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections; Hemophilia A

Keywords

Drug Evaluation; Zidovudine; Hemophilia A

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, 14215, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (4)

• Portmore A, Morse G, Hewitt R, Reichman R. Comparative oral disposition of zidovudine in neutropenic AIDS patients and asymptomatic hemophiliacs. Int Conf AIDS. 1990 Jun 20-23;6(3):196 (abstract no SB442)

  BACKGROUND

• Morse GD, Portmore A, Olson J, Taylor C, Plank C, Reichman RC. Multiple-dose pharmacokinetics of oral zidovudine in hemophilia patients with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1990 Mar;34(3):394-7. doi: 10.1128/AAC.34.3.394.

  PMID: 2334151 BACKGROUND

• Morse GD, Olson J, Portmore A, Taylor C, Plank C, Reichman RC. Pharmacokinetics of orally administered zidovudine among patients with hemophilia and asymptomatic human immunodeficiency virus (HIV) infection. Antiviral Res. 1989 Mar;11(2):57-65. doi: 10.1016/0166-3542(89)90008-9.

  PMID: 2729955 BACKGROUND

• Morse G, Olson J, Portmore A, Taylor C, Plank C, Reichman R. Intravenous and oral pharmacokinetics of zidovudine in hemophilia patients with human immunodeficiency virus infection. Int Conf AIDS. 1989 Jun 4-9;5:278 (abstract no MBP342)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Hemophilia A

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Richard C. Reichman

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 1989
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (2)