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)
2 other identifiers
interventional
N/A
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
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3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1991
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1991-05