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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Alovudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome