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Home > "A" Clinical Trials Conditions > 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)  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)
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)
For Condition: HIV Infections
Status: Completed
Sponsor(s): Lederle Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Additional Information:
Study ID Numbers: 054B; 81-2
Study Start Date:
Record last reviewed: May 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002254
Other Hiv Infections Studies:
1. A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
2. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
3. Fortovase (Saquinavir) Given with Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
4. A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients with HIV-Associated Immune Thrombocytopenic Purpura
5. A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
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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)
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