HIV Infections Clinical Trial
Official title:
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)
NCT number | NCT00002254 |
Other study ID # | 054B |
Secondary ID | 81-2 |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hosp | Baltimore | Maryland |
United States | Univ of North Carolina School of Medicine | Chapel Hill | North Carolina |
United States | Mem Sloan - Kettering Cancer Ctr | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Lederle Laboratories |
United States,
Barditch-Crovo PA, Kornhauser DM, Petty BG, Nerhood LJ, Lietman PS, Faulkner R, Ganes D, Kuye O, Flexner C. Phase I pharmacokinetic evaluation of 3'deoxy-3'-fluorothymidine (FLT), a new potent anti-HIV nucleoside. Int Conf AIDS. 1991 Jun 16-21;7(2):210 (abstract no WB2114)
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