Trials / Completed
CompletedNCT00002254
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Lederle Laboratories · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alovudine |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002254. Inclusion in this directory is not an endorsement.