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| Sponsor: | Lederle Laboratories |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002254 |
Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Alovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Pharmacokinetics Study |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Active substance abuse.
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New York | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Univ of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 275997215 | |
More Information
| Study ID Numbers: | 054B, 81-2 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002254 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome |
|
Alovudine Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Dideoxynucleosides Infection Reverse Transcriptase Inhibitors Pathologic Processes Anti-Retroviral Agents Syndrome Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Disease Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors AIDS-Related Complex Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |