Know Cancer

forgot password

A Phase I Trial to Evaluate Azidothymidine (AZT) in the Treatment of HIV Infections in Patients With Hemophilia

Phase 1
12 Years
Not Enrolling
HIV Infections, Hemophilia A

Thank you

Trial Information

A Phase I Trial to Evaluate Azidothymidine (AZT) in the Treatment of HIV Infections in Patients With Hemophilia

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.

Inclusion 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Richard C. Reichman

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 017



Start Date:

Completion Date:

March 1989

Related Keywords:

  • HIV Infections
  • Hemophilia A
  • Drug Evaluation
  • Zidovudine
  • Hemophilia A
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hemophilia A



Univ of Rochester Medical Center Rochester, New York  14642
SUNY / Erie County Med Ctr at Buffalo Buffalo, New York  14215