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)

Launched by LEDERLE LABORATORIES · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility 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.