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.

Condition	Treatment or Intervention
HIV Infections	Drug: Alovudine

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
New York
      Mem Sloan - Kettering Cancer Ctr, New York,  New York,  10021,  United States
North Carolina
      Univ of North Carolina School of Medicine, Chapel Hill,  North Carolina,  275997215,  United States

Study ID Numbers:  054B; 81-2
Record last reviewed:  May 1991
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002254
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08