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A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)


N/A
18 Years
N/A
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.

- Up to 14 days of systemic therapy for minor opportunistic infections such as
candidiasis, mucocutaneous Herpes simplex or cutaneous Herpes zoster infections.

Patients must have the following:

- AIDS or AIDS related complex (ARC) as defined by the CDC.

- Positive antibody to HIV as determined by a commercially licensed ELISA test kit,
confirmed by Western blot analysis.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the
month prior to study entry (progression is defined as more than a 25 percent increase
in the product of bidirectional measurement of indicator lesions and/or more than a
25 percent increase in the number of new lesions).

- Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin.
Patients who have had a malignancy in the past that has been in complete remission
for 1 year without therapy may be enrolled.

- Signs or symptoms of neuropathy and a Vibratron 2 score = or > 4 for either great
toe.

Concurrent Medication:

Excluded:

- Acute therapy for AIDS-related infection.

- Systemic maintenance therapy for AIDS-defining opportunistic infection.

- Recombinant erythropoietin.

- Long term therapy with either aspirin or probenecid.

Concurrent Treatment:

Excluded:

- Blood transfusion more than once per month.

Patients with the following are excluded:

- Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the
month prior to study entry.

- Unwilling to sign an informed consent or patients unwilling to be followed at the
medical center where they were enrolled for the duration of the study and follow-up
as required.

- History of intolerance to zidovudine (AZT) at any dose as demonstrated by an AZT
related decrease in hemoglobin levels of at least 2 g/dl or AZT related depression of
neutrophils of at least 200 cells/mm3 to < 750 cells/mm3 which required
discontinuation of AZT therapy.

- Diseases or conditions listed in Exclusion Co-Existing Conditions.

Prior Medication:

Excluded:

- Antiretroviral agents within 14 days of study entry.

- Immunomodulating agents or corticosteroids within 30 days prior to study entry.

- Treatment for acute Pneumocystis carinii pneumonia within 2 weeks prior to study
entry.

Prior Treatment:

Excluded:

- Blood transfusions within 7 days prior to study entry.

- Radiation therapy for Kaposi's sarcoma within 30 days prior to study entry.

Active substance abuse.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

054B

NCT ID:

NCT00002254

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • AIDS-Related Complex

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Johns Hopkins HospBaltimore, Maryland  21287
Univ of North Carolina School of MedicineChapel Hill, North Carolina  275997215