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)

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related complex (ARC) after multiple oral dosing for 16 weeks.

Key facts

Study ID

NCT00002254

Run by

Lederle Laboratories

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
• Univ of North Carolina School of Medicine — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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